The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Nepexto, a biosimilar of Enbrel (etanercept), for the treatment of various inflammatory disorders including ankylosing spondylitis.
CHMP is an arm of the European Medicines Agency. and the European Commission generally accepts opinions released by the committee. The commission is now expected to make a decision in May on the potential approval of Nepexto, which is being co-developed by Mylan and Lupin Limited.
“Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe,” Vinita Gupta, Lupin’s CEO, said in a press release. “We are extremely pleased with the positive CHMP opinion on our application. This milestone brings us one step closer to bringing an affordable biosimilar to [Enbrel] to the European market through our partner Mylan.
“Once approved by the European Commission, Nepexto will be our first biosimilar to receive regulatory approval in Europe. Building on this progress, we continue to focus on advancing our biosimilar pipeline,” he added.
Besides ankylosing spondylitis and non-radiographic axial spondyloarthritis (two forms of axial spondyloarthritis), the approval would cover all other indications where Enbrel is currently approved in Europe, namely rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and plaque psoriasis.
This recommendation is based on preclinical and clinical data, including a Phase 3 trial (2015-002809-12) in adults with moderate to severe rheumatoid arthritis that showed that Nepexto and Enbrel have comparable safety, efficacy, and immunogenicity — the capacity to induce an immune response.
Biosimilars are to biologics what generics are to conventional medications — therapies with similar active properties, and with comparable safety and efficacy. The dosing and route of administration of biosimilars are also the same as those of reference biologic medicines. Like generics, biosimilars are intended to introduce competition into the marketplace, which may help drive down costs and expand access.
Two other biosimilars of Amgen‘s Enbrel, Erelzi (by Novartis) and Benepali (by Samsung Bioepis), are already approved in Europe. They are designed to block tumor necrosis factor (TNF), a pro-inflammatory protein.
“We are pleased with the positive CHMP opinion for Nepexto,” said Rajiv Malik, Mylan’s president. “This recommendation validates the strong scientific program supporting this important treatment, which is one of 20 products in our broad and diverse biosimilars portfolio, and our shared commitment with Lupin to help increase access to more affordable biologic treatments, such as etanercept, in Europe and many other regions around the world.”
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