Biosimilars

Based on an OHE lunchtime seminar by Professor Henry Grabowski, this seminar briefing explores the lessons learned from Europe’s experience with biosimilars, and provides an analysis of how the US market may evolve.

OHE’s active involvement in a number of recent conferences and meetings has contributed to discussions on a range of important issue in health economics.

Experts from the three UK HTA agencies, the MHRA, and academia discussed which HTA methods are most appropriate for biosimilars in specific situations.
OHE convened a roundtable to discuss using HTA to assess biosimilars, including which methods are most appropriate in specific situations. Just published is an OHE Briefing that summarises that discussion.

This publication expands on the series of posts published earlier on this blog.   It reports on a seminar intended to encourage further thought about the distinguishing characteristics of the market for biosimilars and...

The law signed in March 2010 eliminated some of the uncertainty about the future of biosimilars in the US. Still unclear is the impact biosimilars actually will have on costs and when any savings might appear.

Biosimilar products in the European Union (EU) must go through a centralised procedure that licenses the product for use in EU Member States. Until experience grows in both approval and use of biosimilars, regulation inevitably will be somewhat case-by-case and concerns about safety will be prominent.

Europe already has some experience with the impact of biosimilars on pricing, including a price war in Germany for EPOs. Whether that experience will be repeated, however, depends on a number of factors, including the originator's pricing strategy and reservations by payers and physicians about potential risks.

Virtually all models forecast that price competition will be less intense and price declines modest in comparison to the generics model. Many models, however, miss or underestimate factors and trends that push the biosimilars market in the other direction. These include, for example, sources of supply with lower variable costs, profit incentives for entry, participation of major pharma companies and an increase in comfort levels over time.

The OHE model varies from other models of biosimilar markets evolution by starting with transaction prices, rather than list prices, and factoring in the collection of 'Patient Safety Year' (PSY) data. These data will capture actual experience with a biosimilar, increasing the comfort level of prescribers and encouraging a gradual increase in market share. PSY data also have important implications for payers and governments, whose options also were outlined in this presentation.

Data exclusivity is critical to ensuring that biosimilars achieve an appropriate balance between increasing market competition and encouraging innovation. The history of 'traditional generics' is a poor guide; biosimilars possess critically different characteristics. In the seminar, Prof Grabowski explored these differences and presented his analyses of data exclusivity requirements for biologics/biosimilars.