Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

Posted 24 March 2017 By Zachary Brennan

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The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis.

Duplicate MAAs: Public Health or Co-Marketing?

Under Article 82(1) of Regulation (EC) No 726/2004, the Commission "shall authorise the same applicant to submit more than one application to the Agency for that medicinal product when there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients, or for co-marketing reasons."

On the public health side, an EC guideline from 2011 on duplicate MAAs notes that applications need to be evaluated on a case by case basis "but arguments that are not linked to the availability of the product cannot be considered."

Likewise, Article 82(1) says: "A co-marketing arrangement is generally understood as an agreement between two parties to commercialise a specific medical product under different trademarks. It is noted that co-marketing requires the existence of two parties; i.e. a request for authorisation under Article 82(1) on co-marketing grounds shall not be accepted when the two marketing entities belong to the same company group."

An Amgen spokesperson did not clarify how the company was able to win approval of the duplicate application but told Focus in an emailed statement: "Duplicate applications are possible under certain circumstances in the EU. Amgen decided on this strategy as we took into consideration a multitude of commercial options that may be present to us at time of launch."

Rebecca Harding, a spokeswoman from the European Medicines Agency (EMA), told Focus: "Amgen was allowed to submit two marketing authorisation applications due to potential existing patents in certain Member States regarding the polyarticular juvenile idiopathic arthritis indication. Apart from that there is no other difference between the two products."

Dr. Duncan Emerton, a UK biosimilars expert, told Focus he thinks the company may end up licensing Solymbic and make royalties off of a collaboration, though he’s unsure.

The practice of EC granting approval of duplicate MAAs is not uncommon, Emerton noted, pointing to Amgen’s previous approval of Ristempa (pegfilgrastim) in 2015 as a duplicate to its Neulasta (pegfilgrastin), which is used in cancer patients to help with some of the side effects of their treatment. Pfizer’s Lifmior (etanercept) was also recommended for approval in 2016 as an identical product to Enbrel (etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.

The EC guideline notes that the submission of duplicate MAAs under Article 82(1) "have increased steadily and this is a trend that is likely to continue in the future as the use of the centralised procedure rises." For more on duplicate MAAs for biosimilars see this EMA Q&A.

Amgen’s Two Humira Biosimilars

The EC approved both biosimilars based on the same data package supporting biosimilarity to adalimumab, based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity were also comparable to the reference product, the company said.

EMA's Committee for Medicinal Products for Human Use (CHMP) in January recommended the two Amgen biosimilars for AbbVie’s blockbuster, first authorized in the EU on 8 September 2003.

AbbVie recently announced Humira sales of $16 billion worldwide for 2016, which came on top of $14 billion for 2015, more than $20 billion from 2014 and 2013.

In the US, Amgevita was approved by the Food and Drug Administration in September 2016, with the brand name Amjevita (adalimumab-atto). Like in the US, the EU biosimilars for Humira likely will not hit the market in 2017.

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Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration, News, Europe, EMA, EC

Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel

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