Piper Jaffray analyst Joshua Schimmer said he is "somewhat disappointed" that Biogen (BIIB) decided to settle with Forward Pharma (FWP) related to patents for Tecfidera, as he did not view the patent as strong to begin with and continues to expect multiple paragraph IV filers to challenge Tecfidera in 2018. However, if this agreement can delay generic entry by just a few months that could cover the cost of the settlement, noted Schimmer. The analyst, who thinks a strong launch for Spinraza in SMA and Alzheimer's optionality more than offset Biogen's fading dominance in multiple sclerosis, keeps an Overweight rating and $335 price target on the stock.

Biogen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for TOFIDENCE, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been recommended for approval for the treatment of moderate to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19. The CHMP's positive opinion will now be referred to the European Commission, which will decide whether to grant marketing authorization for TOFIDENCE. If a marketing authorization is granted by the EC, TOFIDENCE will be an addition to the existing biosimilars portfolio of three widely prescribed anti-TNF biosimilars commercialized by Biogen in Europe: BENEPALI, IMRALDI and FLIXABI, offering an extension to the cost-effective treatment options with an additional mechanism of action. "The positive CHMP recommendation for TOFIDENCE marks another positive step toward helping more people with inflammatory and immune-mediated conditions gain access to leading therapies," said Ian Henshaw, Global Head of Biosimilars at Biogen. "Positive CHMP recommendation for TOFIDENCE is testament to our continuing efforts to develop and deliver high-quality and proven biologic medicines to more patients, healthcare providers and healthcare systems in Europe."

Wedbush analyst Laura Chico raised the firm's price target on Biogen to $215 from $213 and keeps a Neutral rating on the shares. It remains early days for newly launching products like Skyclarys, Leqembi and Zurzuvae, the firm notes. That being said, it is encouraging to start to see revenue growth for Leqembi and continued growth for Skyclarys. Wedbush continues to see a gap between the newly launching products and earlier-stage development programs that will need to be addressed. However, larger-scale BD deals are likely easier to complete in 2025.

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