Biosimilars offer a chance to improve access to, and reduce spending on, life-saving biologic therapies. But could regulators do more to support the market? While experts believe significant regulatory progress has been made in recent years, clarity is distinctly lacking on certain issues, such as interchangeability and naming.
FirstWord’s Biosimilars: Regulatory Outlook provides insight and opinion on why. This 64 page report gives in-depth and candid views on what eight industry and biosimilar experts see as the areas that require the most attention within biosimilar regulation.
You’ll discover expert concerns and views on critical, market-shaping issues, and understand how they see biosimilar regulations evolving in the future in areas such as indication extrapolation, interchangeability, naming, terminology and the amount and type of clinical data needed to support regulatory approvals.
“The EMA has set the tone when it comes to biosimilar regulation. A pathway that, quite rightly, is seen as the gold standard pathway around the world.” EU Biosimilars Expert.
Answering key questions
Get answers to key questions about the regulation of biosimilars, and how the area is set to evolve:
Key issues explored
A report based on expert US and EU industry knowledge
Other experts interviewed for the purposes of this report – who requested anonymity due to the content of their comments – include a biosimilars expert working for a European biotech company, the global head of biologic strategy at a leading European biotech company, the global strategy and commercial lead for a US based biosimilars company, and industry experts from EU and US pharma companies. Emailed comments to specific questions were also received from a spokesperson at Germany’s Paul Ehrlich Institute, one of Europe’s leading regulatory bodies.
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Table of Contents
for Biosimilars: Regulatory Outlook
2.Objectives and methodology
3.Historical review of biosimilar regulation
4.Biosimilar Regulatory Outlook
5.Europe; biosimilars regulation in the European Union has shaped global thinking, and continues to influence regulatory policy around the world
6.US: while being late to the game, the US has made significant progress in recent years, but challenges remain
7.Japan: under the Japanese biosimilar guidelines, developers need to make heavier investment
to get a biosimilar approved compared to generic drugs
8.The implementation of biosimilar guidelines across other markets has generally followed the
9.EMA’s model, with some notable exceptions
10.Australia follows Europe’s lead and implements the EMA’s guidelines en bloc
11.Brazil leans on the World Health Organization’s similar biotherapeutic product guidance for inspiration
12.Canada borrows elements from the European guidelines and provides inspiration for the
14.China bows to international pressure and creates a national biosimilars pathway, but maintains access as an important element
15.India’s guidelines generate controversy due to timing and content
16.Korea’s early foray into developing guidelines seen as supportive of local industry
17.Russia remains without a formal biosimilar pathway, but guidelines expected in the near term
19.Current regulatory situation and key controversies
20.Biosimilar approvals in key developed and emerging markets
21.Europe leads the way with 21 biosimilar approvals and more expected within the next 6-12 months
22.Have the ‘green shoots’ of the US biosimilars market finally been seen? 28 Japan’s biosimilars market gathers pace with several approvals since 2009
23.Other key developed and emerging markets 31 Regulatory controversies, concerns and confusion
24.Despite the EMA’s status as the leading biosimilar regulator, improvements in review timelines
25.Unnecessary clinical data is being generated by some biosimilar developers, with potential
ethical ramifications (Lilly/glargine)
26.Some classes of complex product are being regulated as biologics in some regions,
but not as biologics in other regions
27.The extrapolation of indications is being handled differently by different regulatory authorities,
despite the same data set being reviewed
28.Differences of opinion between regional and national regulatory agencies on the subject
of switching patients from the brand to the biosimilar continue to emerge
29.Transition provisions within the BPCIA remain a cause of confusion and concern for the industry
30.Future regulatory challenges in the biosimilars market
31.Analytics: advances in non-clinical analytics could reduce the amount of clinical data needed,
but won’t remove the need for it completely
32.Emerging markets: these remain a key element of future pharma growth, but will lower regulatory standards create issues?
33.Extrapolation of indications: while based on solid science, concerns and questions continue
to divide opinion
34.Interchangeability in the US: five key questions 55 Will an interchangeable biosimilar ever be approved in the US? 55 What will be the burden of proof? 56 Will there be any commercial benefit for interchangeable biosimilars? 35.Do interchangeable biosimilars make sense in all indications? 58 How can the FDA ensure that interchangeability standards are maintained after the approval
of an interchangeable biosimilar?
36.Naming: conventions in relation to biosimilar naming are likely to diverge, thereby creating confusion 60
37.Terminology: guidance on the use of the word ‘biosimilar’ is needed to ensure the efforts of the EMA and FDA are not taken for granted
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