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Biosimilars: A Global Perspective of a New Market

Opportunities, Threats and Critical Strategies 2014

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BioWorld WebinarSeptember 2014

Mari SerebrovBioWorld Regulatory Editor

Lynn YoffeeBioWorld Executive Editor



Biosimilars Market Heats Up

• Global sales of biosimilars in 2011: $510M

• Global sales of biosimilars in 2013 $1.36B

• Sales are predicted to hit $25B by 2020

• Biosimilars are delivering their promise of savings:

a. 20% to 30% discounts from innovator biologics

b. Up to $33B in savings across the EU alone by 2020

• Diverse group of players



Market Overview: Vital Statistics



Mari Serebrov



Defining Biosimilars

• Alternatives• Biobetters• Biosimilars

• Follow-on biologic (FOB)• Interchangeable biologics• Reference biologics



Biosimilar Pathway Models• European Medicines Agency (EMA)

• World Health Organization (WHO)

• International Conference on Harmonisation (ICH)

• Combination

• Will the U.S. be the 5 th model?



How Similar Must a Biosimilar Be?

In the U.S., comparativeanalytical characterizationmay lead to one of fourassessments:

• Not similar• Similar• Highly similar• Fingerprint-like similarity



A Generics-Like Market or Something Entirely New?

• Separate paths and laws = new market• Regulators see it as a new market• Market uptake so far suggests a new market• R&D costs, failure risks support a new market• Attracting more people

• Sales example to show real Impact is coming from next generation



The Potential Benefits of Biosimilars• Savings in many forms, such as 20%-30% discount

• Access to new markets

• Expanded use

• Provides a price control

• Provides choice



Competing in Emerging Markets• Working in emerging markets

• Unlike generics, partnering is key

• Must manufacture in that country

• Essential drug lists (EDL) challenges in BRIC nations

• In the past, EDLs haven’t included biologics

• Technology transfer



?? Interchangeables ??

• Rules vary by country

• Will the FDA follow suit?



Offense and Defense

• How to compete witha well-establishedbrand

• Brand companiesgave it up to generics,but biologics makersdon’t have to do that



Key Strategies for Makers of Biosimilars• Build a team of experts• Select target markets based on overarching goals• Develop partnerships in those markets• Choose candidates based on target market needs

• Invest in state-of-the-art manufacturing• Build a reputation for quality• Educate doctors, patients and payers about biosimilars• Price accordingly

• Think long term



Key Strategies for Makers of Reference Drugs• Extend IP rights• Aggressively protect IP• Adopt a life cycle approach• Develop improved, proprietary means of administration

• Develop new drugs that offer greater therapeutic benefit• Build brand loyalty and confidence• Improve manufacturing processes• Partner with domestic companies in emerging markets

• Raise the price of biologics in regulated markets



Manufacturing Hurdles• Room for differentiation• Historically, biologics are

hard to make

• Quality

• The solution: Single-usebioreactors



Defend Your Turf

• Just lower your price

• Get on the formularies (Example: Omnitrope)

• Lifecycle approach

• Innovation

• Target the U.S.

• Litigation expectations



All Eyes Are On the U.S.The medical community is aware that the eventual approvalof sales of biosimilars in the U.S. market will signal an agewhere biosimilar MAbs are globally recognized as innovativehigh quality biologics, with equivalency in both efficacy andsafety to their originator products.

“

”

A statement from Korea-based Celltrion Inc., an aggressivebiosimilars developer. Its Remsima, a biosimilar of Janssen’s

Remicade (infliximab), was recognized globally as the first MAb tobe approved on an official biosimilar regulatory path and was the

first biosimilar MAb approved in the EU



Patients in Need of Effective Biologics

• What’s in it for the patients?

• Will price cuts be big enough to benefit society?

• How do patients benefit in trials?

• What’s the effect on overall health care costs?

• Are there too many companies chasing too fewtargets?



Questions



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