Biosimilar round-up: Deal-breaking, approvals, and patents

Mundipharma acquires Cinfa; Sandoz resolves dispute with AbbVie; FDA favours Celltrion and Teva’s rituximab. Welcome to the heady world of biosimilars.

First up is an acquisition in the biosimilars space, with Cambridge, UK-based Mundipharma bolstering its portfolio through the purchase of Spanish drugmaker Cinfa Biotech.

Financial have not been divulged, but Mundipharma gains immediate access to Pelmeg, a biosimilar which is looking to take a slice of the global $4.5 billion pegfilgrastim market.

M&A, patent resolutions and approvals (nearly). It’s been a busy week for biosimilars. Image: Dstanton

Pelmeg received recommendation for approval on September 20 from the EMA’s Committee for Medicinal Products for Human Use, and if approved by the European Commission it will challenge both Amgen’s reference product Neulasta, as well as biosimilar versions Coherus’ Udenyca and Accord Healthcare’s Pelgraz.

Celltrion and Teva

Talking of approvals, Korean drugmaker Celltrion is well on its way to having CT-P10 become the first biosimilar of Roche’s Rituxan (rituximab) receive regulatory thumbs up in the US, after the Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval.

If successful, the product will be marketed in the US by Teva Pharmaceutical Industries after the Israeli drugmaker forged a partnership with Celltrion in 2016 worth US$160 million.

The FDA’s recommendation comes on the second attempt for Celltrion. The FDA issued a complete response letter (CRL) for the rituximab product earlier this year, citing a warning letter​ sent to Celltrion in January highlighting “multiple poor aseptic practices” at its production site in Songdo, Incheon.

The firms are still awaiting recommendation of CT-P6, a proposed biosimilar to Roche’s Herceptin (trastuzumab) submitted for the second time in June.

Novartis vs AbbVie

Novartis subsidiary Sandoz reported this week that the licensing of its proposed Humira (adalimumab) biosimilar Hyrimoz will be available in Europe from October 16, 2018 and on September 30, 2023 in the US.

The license period comes after the firm entered an agreement with reference drugmaker AbbVie, settling several patent disputes. Under terms of the deal, Sandoz will pay royalties to AbbVie for licensing its Humira patents.

“This settlement helps remove uncertainty regarding when our biosimilar adalimumab will be available and allows us to focus on expanding access for patients to the medicine they need to manage their chronic disease,” said Stefan Hendriks, global head of Biopharmaceuticals at Sandoz.

This is the latest patent agreement between AbbVie and a biosimilar maker. Under similar terms, Amgen settled its patent disputes in September 2017, while Samsung Bioepis did likewise in April 2018.

Amgen’s Amjevita became the first US approved Humira biosimilar in September 2016.

Other companies looking to take a slice of the global $18.3 billion – $12.4 billion in the US – adalimumab market include Boehringer-Ingelheim with its approved product Cyltezo.