US FDA defends biosimilar substitution

Biosimilars/General | Posted 01/03/2013 post-comment0 Post your comment

US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, on 20–22 February 2013.

Generic Brand Name V13C01

Commissioner Hamburg said that attempts to undermine trust in biosimilars are ‘worrisome and represent a disservice to patients who could benefit from these lower cost treatments’. She added that ‘substitutability helped spur the growth of the generic[s] industry and is similarly essential to help foster competition in the biological drug market. Ultimately, such competition will spur innovation, improve consumer choice and drive down medical costs.’

The comments came in response to actions by biotech giants Amgen and Genentech, which it is thought may limit the use of biosimilars in the US. Amgen and Genentech are lobbying US states to pass legislation that the generics industry says will create hurdles for the uptake of biosimilars [1]. Amgen, however, has denied the accusations, saying that the company believes that ‘enhanced safety monitoring and transparency of substituted biologicals is in the interest of patient safety’ [2].

At the GPhA meeting executives from top generics companies urged the industry to coalesce and push back at what they deem ‘a pre-emptive strike’, from brand-name companies. Mr Donald DeGolyer, President of Sandoz USA, said that drugmakers, pharmacists, group purchasing organizations and other stakeholders must ‘speak with one voice’ to prevent barriers being put in place by originator companies.

FDA has received 50 requests for initial meetings to discuss biosimilars development covering 12 different reference products. This is interesting to compare with Europe, where to date 14 biosimilars have been approved covering only three reference products [3]. Commissioner Hamburg confirmed that FDA has already carried out 37 initial sponsor meetings and has received 14 Investigational New Drug applications for biosimilars.

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AMAC and GPhA hit back at Big Pharma over biosimilars


1.  GaBI Online - Generics and Biosimilars Initiative. Biotech firms try to limit biosimilar substitution in US []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 1]. Available from:

2.  GaBI Online - Generics and Biosimilars Initiative. Amgen’s response to biosimilar substitution legislation in US []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 1]. Available from:

3.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 1]. Available from:

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Source: Drug Industry Daily, GPhA

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