Samsung Bioepis and Biogen Inc (NASDAQ:BIIB) Closing In On Regulatory Approval for Humira Biosimilar SB5

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Samsung Bioepis and Biogen Inc (NASDAQ:BIIB) have inched a step closer to getting their biosimilar drug SB5 approved for marketing and distribution across Europe. The European Medicines Agency has agreed to review the drug, which if approved will rival Humira on the treatment of severe rheumatoid arthritis and moderate to severe plaque psoriasis.

Positive Phase III Results

The Marketing Authorization Application up for review is based on a Phase III study of the biosimilar drug, which was carried out on 544 patients in a 52-week trial. According to Samsung Bioepis, SB5 achieved an ACR20 response rate of 72.5% after 24 weeks, compared to 72% in the Adalimumab arm. ACR20 is loosely a 20% reduction in symptoms of rheumatoid arthritis. The two arms registered the same safety profile.

Buoyed by the positive results, BiogenSenior Vice President Alpha Seth says the drug will help provide patients a cheaper option for the treatment of arthritis. Humira, as it stands, remains the most prescribed drug for arthritis in Europe with an estimated $4 billion in revenues.

Growing Focus on Biosimilars

The filing of the Marketing Authorization Application further affirms the joint venture desire of bringing to market high-quality biologic therapies that are affordable. If approved, the new drug should help increase patient access to high-quality treatment, while driving down healthcare spending.

Samsung Bioepis CEO, Christopher Hansung KO, says they are working on bringing more biosimilars to market in a bid to provide patients with affordable medicines without compromising health care quality. The company already boasts of a pipeline of 13 biosimilars that cover key areas of treatment such as immunology, oncology, and diabetes.

Samsung Bioepis has also inked a manufacturing partnership with Biogen for the development of anti-TNF biosimilars. While such drugs are manufactured in state-of-the-art drug substance facilities, Biogen and Merck & Co., Inc. (NYSE:MRK) assume the role of distribution and commercialization of any approved drug. Some of the drugs that have already received regulatory approval and are already up for distribution in Europe include SB4 that references Enbrel and SB2 that references Remicade, all similar drugs.

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