Top 10 Things You Need to Know About Biosimilars

1.  Biosimilars are copies of biologics produced by another party which have minor structural differences that do not substantially affect therapeutic activity.

2. Biosimilars will be produced and sold by ‘generics’ manufacturers when the patent has expired on the original biologic.

3. Given that a biosimilar is not exactly the same as the original biologic (unlike the situation with other generic drugs) biosimilars are subject to their own regulatory requirements, which are either in place or which governments are in the process of introducing.  Often a key requirement for approval is the extent to which the biosimilar could substituted for the biologic.

4. Biologics are expensive, with the US spending $320 billion on them each year.  Therefore biosimilars have the potential to give large price-savings. Estimates predict a saving of $100 billion in the US in the first 10 years of biologics being introduced.  Estimates of prices for biosimilars in the US vary between 10 to 40 % less than the prices of the equivalent biologic.

5.  Biologics producers are lobbying for strict regulation of biosimilars to delay their introduction.  This lobbying is at the government level, and in the US also at the state level.  Only Oregon, Utah, Virginia and North Dakota have passed biosimilar legislation.  This month California’s Governor voted down the Biosimilars Bill which had been passed by the California Legislation which aimed to place restrictions on biosimilars.

6. The EU recently approved its first biosimilar antibody. It was called Inflectra and is a biosimilar version of Remicade. Europe’s Remicade market is worth around $2bn.

7.  Many biologic blockbusters face patent expiry in the next 5 years (e.g. Rituxan, Erbitux, Humira and Enbrel) and so now is a crucial time for biosimilar productions and approvals.

8. The Patient Protection and Affordable Care Act created a pathway for biosimilar regulatory approval.  The FDA is working on the details of the pathway.

9.  Abbott petitioned the FDA not to approve a biosimilar for its Humira on the grounds that the FDA would have to use Abott trade secrets, previously submitted to the FDA, when carrying out the approval.

10. The top players in the US biosimilar market are expected to be Sandoz, Hospira, Teva and Amgen/Actavis.  Other players include Samsung/Merck, Pfizer, Celltrion and Boehringer Ingelheim. Outside the US Reliance, Dr Reddy’s and Biocon/Mylan are also expected to be important.

You may also wish to see related articles What do you need to know about commercial biotech and Top 10 Observations on Antibodies