Biosimilar Market: A New Dynamic in Pharmaceuticals

©2013 Waters Corporation 1

Biosimilar Market:

A New Dynamic in

Pharmaceuticals

Confidential


“The development of the biosimilar market will

bring a new dynamic into the Pharma world.…

...with its very specific dynamics, this market

will differ significantly from those for

originator products and for ‘classic’ generics.

In general, biosimilars will be a higher-risk but

also higher-rewarded business compared to

classic generic drugs.”

Accenture Report: “Biosimilars – Emergence of a third market dynamic between original products and generics”

Confidential


Agenda

Definitions and Terminology

Regulatory Landscape

Market

– Size and Forecast

– Drivers and resistors

Stepwise Approach required for Biosimilars

Examples of Biosimilar Challenges

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Terminology

‘Bio-generics’

‘Bio-betters’

‘Follow-on Biologics’ ‘2nd Generation mAbs’

‘subsequent-entry

biologicals/biologics’ ‘me-too

biologicals/biologics’

‘noninnovator

proteins’

‘similar

biopharmaceuticals’

Confidential


Terminology: the term Biosimilars is now widely adopted

‘Bio-generics’

‘Bio-betters’


‘subsequent-entry



‘noninnovator

proteins’

‘similar


BIOSIMILARS

Confidential


Terminology: the term Biosimilars is now widely adopted

‘Bio-generics’

‘Bio-betters’


‘subsequent-entry



‘noninnovator

proteins’

‘similar


BIOSIMILARS

Referred to as Similar Biotherapeutic Product (SBPs)

by WHO

Referred to as Subsequent Entry Biologics (SBPs)

By Canada

Referred to as Biocomparables

By Mexico

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Definitions relating to Biosimilars

Biosimilar or Biosimilarity means:

“the biological product is highly similar to the reference product not

withstanding minor differences in clinically inactive components”

And

“there is no clinically meaningful differences between the

biological product and the reference product in terms of safety,

purity, and potency of the product”

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“Alternative” biologics are NOT Biosimilars

“Non-Comparable biologics” (not highly similar to a Approved Reference Product)– not approved in highly regulated markets– are NOT biosimilars Confidential


Biosimilar Legislative Landscape Pathways Opening Globally

FDA: Legal pathway established 2012; Draft FDA Guidelines

EMA: Established regulation in 2005 and guidelines 2006, including finalization of mAb guidelines 2012.

Health Canada: Guidelines published Released 2010. Global reference product accepted.

Japan: Final guidelines established based on EU process 2009.

Non-ICH: Disperse regulatory requirements, WHO Harmonization in process; release final Guidance in 2010

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In June 2012 the European Medicines Agency finalized two documents with guidance on how to develop medicines containing monoclonal – Guideline on similar biological medicinal products

containing monoclonal antibodies – non-clinical and clinical issues

– Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use

Public consultation period ran from November 2010 to May 2011 with final versions adopted in May 2012.

Both guidelines in effect on December 1, 2012.

In July 2013, the first two monoclonal antibody biosimilars were approved in Europe – Remsima and Inflectra

– Both contain the same known active substance, infliximab.

Europe and monoclonal antibodies

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WHO Guidelines

“Guidelines on Evaluation of Similar

Biotherapeutic Products (SBPs)” was

developed and adopted by the 60th

meeting of the WHO Expert Committee on

Biological Standardization in 2009.

WHO has published guidelines on the

evaluation of biosimilars in order to

facilitate the global harmonization for both

regulatory bodies and the pharmaceutical

industry

WHO has recommended EU legislation/

guidelines as a WW model

– EU legislation for Biosimilars in place since

early 2000’s, first guidelines adopted in 2006.

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Status of Biosimilar Legislation and Guidance

China: No clear pathway, favoring local products

Hong Kong: No clear pathway

Russia: No guidelines yet

India: Guidelines established and implemented August 15, 2012; alternative pathway for local products

S. Korea: Guidelines established similar to EU Guidelines; alternative pathway for local products

Turkey: Adopted EU Guidelines

Switzerland: Adopted EU Guidelines

New Zealand: Biosimilar to follow EU guidelines

Australia: Adopted overarching Guidelines similar to EU, and adopted product-specific EU Guidelines

Saudi Arabia: Guidelines Established

Malaysia: Guidelines established

Singapore: Guidelines Established

Malaysia: Guidelines established

Argentina Guidance established in 2008

Brazil Guidance established for biosimilars in 2010

Chile Draft Guidance in 2011

Mexico Guidance effective April 2012, called biocomparables

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There are five well recognized principles with regard to the assessment of biosimilar products:

– The generic approach is not appropriate for biosimilars

– Biosimilar products should be similar to the reference in terms of quality, safety, efficacy

– A step-wise comparability approach is required that indicates the similarity of the Biosimilar to Reference Biological Product in terms of quality is a prerequisite for the reduction of non-clinical and clinical data submitted

– The assessment of a biosimilar is based on a case-by-case approach for different classes of products

– The importance of pharmacovigilance is stressed

No significant difference in the general concept and basic principles of all guidelines

If Biosimilar candidates shown to be “highly similar” at the analytical level, this can result in streamline pre-clinical and clinical studies If the product attributes of Biosimilar candidate deviate from the reference, this can increase pre-clinical and clinical studies requirements.

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Comparing EMA and FDA - Similarities

Definition of Biosimilar: Similarity is assessed by structural and functional

comparisons to an approved reference product

Stepwise Approach to Demonstrating Biosimilarity: Starting with detailed

structural characterization of the proposed biosimilar and its reference product,

followed by preclinical then clinical characterizations, makes allowances for

product-specific differences in analytical techniques and clinical endpoints

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EMA Guidance Today

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Comparing EMA and FDA

FDA

– Case –by-case

o 3 very general draft guidelines

• Scientific Considerations in Demonstrating

Biosimilarity to a Reference Product

• Quality Considerations in Demonstrating

Biosimilarity to a Reference Protein Product

• Biosimilars: Questions and Answers Regarding

Implementation ofSp the Biologics Price

Competition and Innovation Act of 2009

– Reference product that was previously

licensed by FDA, but does provide the

provision to use data derived from animal or

clinical studies comparing a proposed

product to a non-US-licensed product.

Adequate data is required to justify

relevance.

EMA

– Class-by-Class

o Guidance for the various classes of

biopharmaceuticals as well as general

guidelines

o Specific guidelines include:

• Recombinant erthroepoetin

• Recombinant human insulin

• Granulocyte-colony stimulating factor

• Interferon

• Monoclonal Antibodies

– No provision for non-EMA licensed

reference products in current guidance

– As of Sept 2012, EMA announced its

intent to revise guidance to accept

biosimilar reference product sourced

outside Europena Economic Area. Agency

expects to release draft for public

consultation in early 2013.

Confidential


WHO Guidance on Reference Product

National regulatory bodies have required the use of a

nationally licensed reference product for licensing of

generic medicines.

WHO recognizes that this practice may not be feasible

for countries lacking nationally-licensed Reference

Biological Products (RBPs).

WHO provides considerations for choosing a RBP

Note: Only Canada explicitly allows the use of a non-Canadian

reference product.

Confidential


FDA

– Interchangeability means automatic substitution which refers to the practice of dispensing one medicine instead of another equivalent and interchangeable medicine at the pharmacy level without requiring consultation with the prescriber.

– FDA did not cover the issue in its recently issued draft guidances – except in the Q&A document:

Q. I.14. Can an applicant obtain a determination of interchangeability

between its proposed product and the reference product in an original 351(k) application?

A. I.14. (Proposed Answer): Yes. Under the BPCI Act, FDA can make a determination of interchangeability in a 351(k) application or any supplement to a 351(k) application. An interchangeable product must be shown to be biosimilar to the reference product and meet the other standards described in section 351(k)(4) of the PHS Act. At this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability in an original 351(k) application given the statutory standard for interchangeability and the sequential nature of that assessment. FDA is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable with the reference product.

Automatic interchangeability cannot be applied to all biosimilars in the US. Have to meet the higher standard of interchangeability

EMA

– Interchangeability refers to the

“doctor’s ability to prescribe a

biosimilar in place of the reference

product”

– Substitutability is to allow

“pharmacists to dispense a

biosimilar rather than the reference

drug”.

o Substitutability is clearly a more

contentious issue

EMA has been silent about

interchangeability, but has made

statements opposing the idea of

automatic substitution of biosimilars

(for example, at the pharmacy level)


Confidential


“Interchangeability”

The debate on substitutability and interchangeability of ultimately addresses the question of how similar biosimilars are or should be in order to qualify for substitutability and interchangeability

The main parties and stakeholders in this debate are

– Originators

– Generics/biosimilars industries and their respective trade associations

– Drug regulatory agencies & WHO

– Insurers/payers

– Doctors & pharmacists

– Patients

A consequence of this is that companies will need to invest significantly in marketing to assure that their biosimilars are used

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FDA

– Requirement for Safety and Efficacy Trials: “As a scientific matter, comparative safety and

effectiveness data will be necessary to support a

demonstration of biosimilarity if there are residual

uncertainties about the biosimilarity of the two

products based on structural and functional

characterization, animal testing, human PK and

PD data, and clinical immunogenicity

assessment. A sponsor may provide a scientific

justification if it believes that some or all of the

these comparisons on clinical safety or effectiveness

are not necessary.”

– Exclusivity Period:

o A section (k) application may not be filed until 4

years after reference product approval.

o A biosimilar may not be approved until 12 years

after reference product approval”

EMA

– Requirement for Safety and Efficacy

Trials: “Usually comparative clinical trials will

be necessary to demonstrate clinical

comparability between the biosimilar and the

reference medicinal product”

– Exclusivity Period:”8 +2+1:

o A biosimilar application may not be filed until 8

years after the reference product approval.

o A biosimilar may not be approved until 10

years after reference approval.

o The market exclusivity may be extended by an

additional year if the reference product sponsor

obtains approval for a second significant

indication during the data exclusivity period.

Confidential


International Non-proprietary Name (INN) and Biosimilars in Europe

The European Commission’s Directive 2012/52/EU of 20 December 2012 – Requires that Member States of the EU recognize medical prescriptions issued in

other Member States

– To enable this recognition, the Directive states that ‘in order to enable the correct identification of products’ the INN or common name should be used.

However, in the case of biological products, the Directive makes an exception – In contrast to small-molecule drugs, biological products are required to

use the brand name.

– This is stated in the Directive as necessary in order ‘to ensure clear identification’ of the biological product because of the ‘special characteristics’ of these products.

Biosimilars manufacturers would of course prefer that biological products were prescribed by INN – Allows for possible substitution in the future

– Enables biosimilars to grab a bigger market share.

– Prescribing by brand requires much more intensive marketing by biosimilars manufacturers in order to increase brand awareness and encourage doctors to prescribe and patients to request biosimilars.

Source: Europa

Confidential


Biologics Market

Sales of biologicals have almost doubled from

US$63.8 billion in 2006 to US$124.6 billion in

2012.

The global biologics market ~$150B today

and expected to be $252B by 2017

By 2014, 7 out of 10 of the top brands will be

biologics

Majority of companies have biologics in their

pipeline

Many biologics are focused on unmet needs

PhRMA Report Medicines in Development Biotechnology2011

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EU vs US Patent Expiry Dates

Sources: http://www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020 http://www.genengnews.com/insight-and-intelligenceand153/biosimilars-10-drugs-to-watch/77899804/?page=1 http://www.terripinn.com/biosimilar

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http://www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020



















http://www.genengnews.com/insight-and-intelligenceand153/biosimilars-10-drugs-to-watch/77899804/?page=1













http://www.terripinn/biosimilar


Expiry dates for major patents on best-selling biologicals

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Bisimilars in the US 2013

Guidance’s are not final

Abbott’s citizens petition to the FDA

States’ decisions for substitution – Legislation which permits pharmacists to dispense a biosimilar that has been

licensed by FDA as interchangeable

– With the following provisions:

o Unless the prescriber indicates such substitution is not authorized or the patient

insists on dispensing of the prescribed biological product.

o Requires any pharmacist who dispenses an interchangeable biosimilar to inform

the patient prior to dispensing the biosimilar, provide notification of the

substitution to the prescriber (Notification can range for 24 hr to 10 days)

o Requires records of the brand name or the product name and name of the

manufacturer of the biosimilar on the record of dispensing and the prescription

label (records can range from 2-10 years)

– To date of the 17 states that have considered this bill, only North Dakota has

passed this intact, and Virginia and Utah with subset clauses. For 6 the decision is

still pending, 2 are reviewing further, 6 have rejected the provisions

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Top 10 Blockbuster Biological in 2012

Seven of the top 10 blockbuster biologicals are antibodies

The anti-TNF antibody Humira (adalimumab) is the top selling single brand of a recombinant biological;

with 2012 sales of US$9.5 billion

The patents on almost all of these biological blockbusters will be expired by 2020, apart from Enbrel

(etanercept) where the US patent has been extended to 2028

Excluding Enbrel, just these 9 biologicals will open up around US$55 billion in sales to competition from

biosimilars.

Confidential


Biosimilars Market Forecast 2010 to 2017

In 2010, the combined biosimilars market size for the US and five major

European markets was $172M

In 2015, the market should be between $2B and $4.8B

– Datamonitor estimated that market will grow from $243m in 2010 to $3.7bn

in 2015. *

– $1.9-2.0B by 2015**

– $4.8B***

By 2017, US$3,987 million****

Annual growth rate of 56.7% expected from 2010 to 2017

*Datamonitor ** IMS Health, December 2011 *** Global Industrial Analysts **** Frost & Sullivan

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Market Drivers and Resistors

Economic Drivers: The governments and/or payers have to pay more

every day for medicines when they are trying to control their budgets

– Poor economy

– Health budget reductions and profit margins

– Biosimilar price around 70-80% of orginator

Legal and Commercial Drivers: Patent expiries is the most critical issue

in biosimilar development. Upcoming patent expiries of monoclonal antibody

drugs will boost biosimilar sales in US and Europe

– Patent expiry

– Uncontested sub-classes of biologics with expired patents

– Co-development and co-commercialization opportunities

Confidential


Cost of Biopharmaceutical Treatment Today

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Clinicial Drivers: Although the topic is clinical, the benefits are related to

economic policy of biosimilars – cheaper medicines will be used more widely

and will help more people to see the benefits

– Lower cost may allow long-term treatment which can potentially translate in

improved survival, quality of life and disability outcomes

– Biologics might be increasingly used as initial treatment

Scientific and Regulatory Drivers: Decades of scientific advances since

the first biologic and the efforts of the regulatory bodies to provide guidance will

be a benefit to biosimilar manufacturers

– Advances in analytical techniques

– Regulatory experience with approvals and interactions with the industry

– WHO guideline and US biosimilar legislation now in place

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Commercial Resistors: Biotechnological manufacturing is definitely more

difficult and expensive than that for small molecule drug. There will be high

level of competitions with so many players in this market.

– Requires strong manufacturing capabilities

– Outsourced manufacturing can be accompanied with greater risk and

uncertainties over price flexibility

– Opposition from innovators

– Competitions (over 150 biosimilar players globally)

– Cost of clinical studies may be higher than originally anticipated

– No experience in branded products

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Key players in Biosimilars

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Legal Resistors: Several innovators are interest in biosimilar business and

may try to control market. Interchangeability, substitution, exclusivity to the first biosimilar, etc are still unclear

– Unclear exclusivity

– Lack of time on the market

– Threat of acquisition by innovators or larger generic companies

Clinical and Regulatory Resistors: Perception and acceptance regarding

Biosimilars among prescribers and patients is not the same in every country. And originators are development new biologics to change the treatment regime is a threat to biosimilars

– Uncertainty over long-term safety risks

– Poor level of understanding from prescribers and patients

– Regulatory and pharmacovigilance burden

– Lack of regulatory consistency and globally harmonized approach

– Potential changes in treatment paradigm

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High-level Overview – Comparison of generics, biosimilars and biologics (Source Accenture Research)

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Complexity

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Amino Acid Substitution

N- and C-terminal modifications

Mismatched S-S bonds

Folding

Truncation

Aggregation

Multimer Dissociation

Denaturation

Acetylation

Fatty acylation

Deamidation

Oxidation

Carbamylation

Carboxylation

Formylation

γ- Carboxyglutamylation

O-linked Glycosylation

N-linked Glycosylation

Methylation

Phosphorylation

Sulphation

PEGylation

Protein Heterogeneity

Confidential


Proteins Modifications Impact different proteins differently

e.g., Methionine oxidation inhibits activity of some protein, but

not others

e.g., Deamidation may increase immunogenicity in one protein

but not another

Confidential


Which attributes matter and which don’t?

Understanding relationship between protein

attributes and clinical safety & efficacy profile

aids ability to predict clinical similarity

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More Analytical Data Required

CMC Strategy Forum 2012, E. Shacter

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Structural Analysis

Generally, such tests include the following comparisons of the

drug substances of the proposed product and reference product:

– Primary structures, such as amino acid sequence

– Higher order structures, including secondary, tertiary, and

quaternary structure (including aggregation)

– Enzymatic post-translational modifications, such as glycosylation and

phosphorylation

– Other potential variants, such as protein deamidation and oxidation

– Intentional chemical modifications, such as PEGylation sites and

characteristics

Guidance for Industry Scientific Considerations in Demonstrating Biosimilarity to a Reference Product U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

Confidential


Functional Analysis

The pharmacologic activity of protein products can be evaluated by in vitro and/or in vivo functional assays. These assays may include, but are not limited to, – Bioassays

– Biological assays

– Binding assays

– Enzyme kinetics.

A functional evaluation comparing a proposed product to the reference product are used to: – Support ”that there are no clinically meaningful differences between the proposed

product and the reference product”

– Scientifically justify a selective and targeted approach to animal and/or clinical testing

– Provide additional evidence that the MOA of the two products is the same to the extent the MOA of the reference product is known.

– Provide additional data to support results from structural analysis

– Investigate the consequences of observed structural differences, and explore structure activity relationships.

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Bioequivalence

The regulatory agencies realize that testing the bioequivalence of biosimilars differs from that of the standard generics.

Small Molecule Drugs – Testing is required for orally ingested products because they maybe absorbed into

the bloodstream at different rates or in different amounts

– Generic drug manufacturers to prove their formulation exhibits bioequivalence to the innovator product

– FDA requires the bioequivalence of the generic product to be between 80% and 125% of that of the innovator product

Biologics – Route of administration is usually via injection directly into bloodstream

o Two injected products are generally bioequivalent in terms of bioavailability

– But they may behave differently once in the body

o The manufacturers of biosimilars must fulfill the quality, efficacy and safety requirements

o The bioequivalence testing procedures for biosimilars are to be performed against the originator product as a control and include preclinical and clinical testing

o Due to varying nature of the biopharmaceutical drugs, many of the concepts discussed in these guidelines may have to be adapted on a case-by-case basis.

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General comparison of requirement

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General comparison of requirement

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Rapid Comparison of a Biosimilar candidate to an innovator

mAbs 2:4, 1-16; July/August 2010; © 2010 Landes Bioscience Confidential


Collaboration

Company X is recognized for a proven track record in generic

small molecule pharmaceuticals.

They wished to expand to produce biosimilar antibodies.

They collaborated with Waters to exploit UPLC and TofMS

technologies to support this new effort.

They were expecting only minor differences from the

innovator company mAb.

Graphic: http://en.wikipedia.org/wiki/File:Antibody2.JPG

= ?

Confidential


Qtof in Biopharma

QTof

– Accurate mass of precursor and product ions

– Ability to quantitate (4 orders in-spectral range)

– Comprehensive CID fragmentation

– Ability to predict fragmentation patterns and automate processing

For Biologics:

– Complexity of samples and high degree of ambiguity needs more 'power'....

– Need for comprehensive characterization (TOF: 'unlimited' mass range; same platform for intact and peptides

– Solves complex problems ('automatically', if MS^E and processing is applied)

MSe

– Ability to apply a generic method without pre-knowledge

– Comprehensive fragmentation and quantification without precursor isolation

– No bias due to abundance (unlike DDA)

– Advantages of processing MS^E info automatically

– Saves time

Confidential


Deconvoluted Spectra of the Heavy Chain

Biosimilar Heavy chains shifted -32 Da consistent with intact data

Innovator mAb

“Biosimilar” mAb

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MIRROR MAP shows Difference Due to Unknown Peak in Biosimilar Sample

New, Unknown Peak in BIOSIMILAR sample at m/z 1872.96

Changes clear in mirror plot

Peptide T34-35 (missed cleavage) confirmed in INNOVATOR with MSE

Significant Differences are visually salient

INNOVATOR (chromatogram)

BIOSIMILAR (chromatogram)

INNOVATOR (spectrum)

BIOSIMILAR (spectrum)

Confidential


Sorting out the T35 differences

Drugbank Herceptin™ HC T35 sequence is DELTK

– Drugbank database entry DB00072

– www.drugbank.ca/drugs/DB00072

Genentech Herceptin™ HC T35 sequence is EEMTK

– Mass is 32 Da heavier.

– Consistent with the marketed product

– REF: Journal of Chromatography B, 752 (2001) 233–245; Identification of multiple

sources of charge heterogeneity in a recombinant antibody. Harris et al.

Result: Incorrect protein sequence (Asian allotype) was cloned and expressed by Company X. Impact: The biosimilar candidate is not the same protein as the innovator and would be considered a new drug. $$$

Confidential


The Importance of High Order Structure for Biosimilars – An

example of a Failed Submission

“…it appears as if the Marvel

insulin tends to be more rapidly

absorbed than the reference

insulin…. One reason for these

results may be that the three-

dimensional structure of the

two insulins were not

identical and that, subsequently,

the forces that keep the insulin

monomers together as an insulin

hexamer … are weaker with

Marvel insulin than with other

[insulins]”.

Confidential


Waters and Japanese Pharmaceuticals and

Medical Devices Agency (PMDA)Collaboration - Insulin Higher Order Structure

Produced for ASMS 2012 – study helped understand the

dissociative events of insulin oligomers

We determined two particular regions which exhibited higher

deuterium uptake in Lispro, which are likely to be involved in

hexamerization and dimerization

Confidential


A Real Biotech Example – Genzyme

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme - 21. January 2010 23:52 http://www.news-medical.net/news/20100121/Genzyme-receives-PDUFA-date-from-FDA-for-its-Biologics-License-Application-for-Lumizyme.aspx

Change of reactor led to Change in Glycosylation Pattern

160L Reactor

4000L Reactor

4000L Reactor

Glycosylation Pattern B Glycosylation

Pattern A

160 L Reactor

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A Real Biotech Story – Genzyme (now Sanofi)

Genzyme receives PDUFA date from FDA for its Biologics License Application for Lumizyme - 21. January 2010 23:52 http://www.news-medical.net/news/20100121/Genzyme-receives-PDUFA-date-from-FDA-for-its-Biologics-License-Application-for-Lumizyme.aspx

Biotech company had to re-submit as a new product

Glycosylation B Not COMPARABLE to Glycosylation A

US: New Clinical Trials

US: Resubmission for New Product

(No guidelines were in place)

EU: (fast) Submission as Biosimilar

EU: Limited Clinical Trials

4000L Reactor

Glycosylation Pattern B

Glycosylation Pattern A

160 L Reactor

ESTIMATED COST > 40 M USD

Confidential


Implications for Biosimilars

How much “similarity” do we

need?

– The requirement to understand

relationship between protein

attributes and clinical safety &

efficacy profile aids ability to

predict clinical similarity

– Know which attributes matter and

which don’t

Thus the Stepwise and Totality of

the Evidence Approaches

– Combine rigorous physicochemical

data with functional studies

– Case-by-case evaluation of

potential clinical impact

Confidential


Portfolio of Solutions for Structural Analysis

UPLC

– Amino Acid Analysis

– Peptide Mapping

– Released Glycan Analysis

– Intact RP

– Intact SEC

– Intact IEX

UPLC/MS

– Peptide mapping

– Glycan Analysis

– Intact Analysis

– HDX

– HCPs

Confidential

http://www.waters.com/waters/nav.htm?cid=10046886









Confidential

Biosimilar Market: A New Dynamic in Pharmaceuticals

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