FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster

Regulatory NewsRegulatory News | 11 July 2016 |  By 

Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.”

“In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between GP2015 and US-licensed Enbrel in terms of the safety, purity, and potency of the product,” FDA staff wrote ahead of Wednesday’s Arthritis Advisory Committee meeting, which will give a more formal thumbs up or down and then will go before FDA for a final decision.

The good news for Sandoz (which comes as the company has been working for more than three years on its application) follows a similarly positive report from FDA staff last Friday, noting that Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab) also has “no clinically meaningful differences.”

And like Amgen’s Humira biosimilar, FDA staff said Sandoz “has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that GP2015 should receive licensure for each of the indications for which US-licensed Enbrel is currently licensed and for which GP2015 is seeking licensure.”

The news from FDA on its advisory panel comes as in January, the European Commission signed off on an Enbrel biosimilar from Samsung Bioepis. According to the Generics and Biosimilars Initiative, at least 11 other companies are also developing biosimilar versions of Enbrel, all of which will cut into Amgen's Enbrel sales.

And on the intellectual property front, Amgen has already sued Sandoz over infringing on Enbrel’s patents as part of an effort to stop the biosimilars from coming to market.

A Sandoz spokeswoman told Focus that the company (unlike many others in the biosimilars space (ie. Amgen’s FDA action date for its Humira biosimilar is 25 September 2016)) does not disclose FDA action dates, which are based on the user fee negotiations, which for biosimilars is called the Biosimilar User Fee Act (BsUFA).

Advisory Committee

In addition to discussing whether GP2015 and US-licensed Enbrel are “highly similar,” as well as whether the totality of data justifies approving the biosimilar for four other indications for which Enbrel is licensed, the committee on Wednesday will vote on: “Does the totality of the evidence support licensure of GP2015 as a biosimilar to US-licensed Enbrel for the following indications for which US-licensed Enbrel is currently licensed and for which Sandoz is seeking licensure (Rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis)?”

FDA and Sandoz Briefing Documents

2016 Meeting Materials, Arthritis Advisory Committee



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