EMA Approves First MAb Biosimilars

By Dan Stanton

- Last updated on GMT

EMA Approves First MAb Biosimilars

Related tags Monoclonal antibodies

The European Medicine’s Agency (EMA) has approved the first biosimilar monoclonal antibodies and expects to approve increasingly complex biosimilars as the regulatory framework becomes more flexible.

On June 28 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) marked the extension of the biosimilar concept by approving two monoclonal antibody (MAb) biosimilars, Remsima and Inflectra produced by South Korean drugmaker Celltrion and marketed in parallel by Celltrion and Hospira respectively.

Remsima and Inflectra contain a version of the MAb infliximab, originally authorised in the biological product Remicade, Johnson & Johnson and Merck & Co's rheumatoid arthritis drug. According to the EMA – who recently released draft guidelines on biosimilars​ - they demonstrate similarity to Remicade in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise.

This approval, EMA spokesperson Monika Benstetter told Biopharma-Reporter.com, “has shown that the biosimilar concept can also be applied to structurally complex substances such as monoclonal antibodies.

“This shows the flexibility of the regulatory framework for biosimilars, which has evolved over time allowing approval of increasingly complex biosimilars.”

Europe has seen just twelve biosimilar approvals since 2006, and the approval of these MAb copycats led us to ask Benstetter whether this would signify an increase in biosimilar authorisations. She said the EMA is “not expecting that their approval will open ‘floodgates’, but rather that the steady stream of applications for biosimilars will continue.”

Hospira Hopes for ‘Bio-Similar’ in US

Spokesman Dan Rosenberg from Inflectra marketer Hospira told Biopharma-Reporter.com the firm expects “Inflectra to provide an opportunity to increase patient access to more affordable biologic therapy”​ in Europe, a region it currently has two marketed biosimilars in, Retacrit and Nivestim.

However, across the Atlantic the US Food and Drug Administration (FDA) has yet to have approved any biosimilars, though has released a series of draft guidelines for industry review​.

“We’ve commended FDA on issuance of draft guidance for biosimilar products and for its continued commitment to support cost competitiveness and wider patient access to this important class of products,” ​said Rosenberg.

“The overall guidance is very consistent with our ongoing dialogue with the FDA, and there is alignment with the agency on many of the concepts we have proposed.”

He added Hospira is also partnering with Celltrion on the biosimilar of Genentech’s cancer treatment Herceptin, containing the monoclonal antibody trastuzumab. Furthermore, the two companies have six other pipeline drugs they are working on which they have yet to disclose.

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