FDA approves the entrance of two biosimilars

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/Evgeny_D)
(Image: Getty/Evgeny_D)

Related tags: Pfizer, Samsung bioepis, Merck, Humira, Rituxan

US FDA gives approval to Samsung Bioepis’ Humira biosimilar and Pfizer’s Rituxan biosimilar, as the number of such medicines gaining entry onto the US market steadily increases.

The US Food and Drug Administration (FDA) validated the applications for two biosimilars, Pfizer’s Ruxience (rituximab) and Samsung Bioepis Hadlima (adalimumab) – extending the biosimilar portfolios of both companies.

With the approval of Samsung Bioepis’ Humira biosimilar, Hadlima, the company noted that it has secured its third FDA approval of 2019 – after having previously received approvals for Ontruzant (trastuzumab) and Eticovo (etanercept).

Merck, known as MSD outside of North America, will be responsible for commercializing Hadlima in the US, becoming one of a number of rival products​ set to enter the market in 2023. Samsung Bioepis stated that the product will be launched after June 30, 2023.

For Pfizer, the approval sees the company gains its seventh approved biosimilar product in the US.

Pfizer’s Ruxience is the second biosimilar approved for Roche’s Rituxan, which is used in the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis.

Andy Schmeltz, global president of Pfizer Oncology, said, “The FDA approval marks our third oncology biosimilar to be approved in the US this year, reinforcing our commitment to bring these important medicines to patients living with cancer.”

Is biosimilar uptake on the uptick?

Questions marks were raised about the sustainability of the US biosimilar market, after Pfizer previously announced that it would cease development on five biosimilar candidates and shed 150 jobs​ from its biosimilar division.

A report suggested that part of the issue has been the lack of uptake of biosimilars in the US, which is costing the US health care system $7.2bn (€6.46bn) every year​ – whilst also dampening revenue generation for companies in the area.

The FDA has looked to act on this perceived failing, with approvals and applications increasing​ over the course of 2018. The two approvals represent the 22nd​ and 23rd​ biosimilars approved by the US FDA.

The potential for the products to have an impact on the price of certain products, such as insulin, has also been highlighted​ by acting FDA commission, Ned Sharpless. However, even in this area, Samsung Bioepis and Merck ceased development of an insulin biosimilar after gauging that the investment would not provide a sufficient return.

Related topics: Markets & Regulations, Biosimilars

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