Biosimilars: A Global Perspective of a New Market

Opportunities, Threats and Critical Strategies 2014

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BioWorld Webinar
September 2014

Mari Serebrov
BioWorld Regulatory Editor

Lynn Yoffee
BioWorld 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 5th model?

How Similar Must a Biosimilar Be?

In the U.S., comparative
analytical characterization
may lead to one of four
assessments:
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 havent included biologics

Technology transfer

?? Interchangeables ??
Rules vary by country
Will the FDA follow suit?

Offense and Defense

How to compete with
a well-established
brand
Brand companies
gave it up to generics,
but biologics makers
dont 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-use
bioreactors

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 approval

of sales of biosimilars in the U.S. market will signal an age

where biosimilar MAbs are globally recognized as innovative
high quality biologics, with equivalency in both efficacy and
safety to their originator products.

A statement from Korea-based Celltrion Inc., an aggressive

biosimilars developer. Its Remsima, a biosimilar of Janssens
Remicade (infliximab), was recognized globally as the first MAb to
be approved on an official biosimilar regulatory path and was the
first biosimilar MAb approved in the EU

Patients in Need of Effective Biologics

Whats in it for the patients?
Will price cuts be big enough to benefit society?
How do patients benefit in trials?
Whats the effect on overall health care costs?
Are there too many companies chasing too few
targets?

Thank You for Joining Us Today

For a copy of the report, call:
U.S. and Canada: +1-800-336-4474
Outside the U.S.: +44-203-684-1796
Or visit:
http://www.bioworld.com/biosimilars2014
Mari Serebrov
Regulatory Editor
Mari.Serebrov@ThomsonReuters.com
(770) 810-3141
Lynn Yoffee
Executive Editor
Lynn.Yoffee@ThomsonReuters.com
(770) 810-3123

Questions

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