Biogen (BIIB Quick QuoteBIIB - Free Report) is facing multiple challenges. Most of its key drugs are facing declining sales. Biogen’s multiple sclerosis (MS) revenues have been declining for the past few quarters. Importantly, sales of its key MS drug Tecfidera are declining, hurt by the launch of multiple generics products in the United States. The company expects further erosion of the drug’s sales in the second half of 2022 as generic versions are expected to be launched in Europe.

Regulatory applications seeking approval for a biosimilar referencing another MD drug, Tysabri have been filed in both the United States and Europe. A biosimilar could be launched upon approval in both the United States and EU in 2023, which can hurt sales.

Sales of Biogen’s spinal muscular atrophy (“SMA”) treatment, Spinraza are being hurt due to a decrease in demand as a result of increased competition from Novartis’ (NVS Quick QuoteNVS - Free Report) new SMA treatment, Zolgensma and Roche (RHHBY Quick QuoteRHHBY - Free Report) and PTC Therapeutics’ Evrysdi (risdiplam) and unfavorable pricing.

Novartis’ Zolgensma was approved in May 2019 while Roche/PTC Therapeutics’ Evrysdi was approved by the FDA in August 2020.

Biogen’s new Alzheimer’s drug, Aduhelm, approved by the FDA in June 2021, failed to generate meaningful sales.

In April 2022, The Centers for Medicare & Medicaid Services (“CMS”) released its final National Coverage Determination (“NCD”) decision for the class of anti-amyloid antibodies approved by the FDA, like Aduhelm. Per the final NCD decision, Medicare said it will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies. The final NCD decision basically denied all Medicare beneficiaries access to Aduhelm, which reduced demand for Aduhelm to a minimal level. As a result of the NCD decision, Biogen decided to substantially wind down commercial operations for Aduhelm, retaining only minimal resources to manage patients’ access programs.

In Europe too, Biogen withdrew its marketing application for aducanumab as the European regulatory body suggested that the data would not be sufficient to support a positive opinion for approval of the drug by the European Medicines Agency (EMA).

Meanwhile, pricing pressure and currency headwinds are hurting sales of Biogen’s biosimilar products. Biogen and partner Samsung BioLogics market three anti-TNF biosimilars in the EU – Flixabi (a biosimilar referencing Remicade), Benepali (a biosimilar referencing Enbrel) and Imraldi (a biosimilar referencing Humira) through Samsung Bioepis, the joint venture between the two companies.

Also, revenues from Biogen’s share of profit from Roche’s drugs, Rituxan and Gazyva declining due to biosimilar competition and the impacts of COVID-19.

Despite all these challenges, we are hopeful that potential new product launches such as lecanemab, zuranolone and additional biosimilars can help revive growth.

Biogen has a collaboration agreement with Sage Therapeutics (SAGE Quick QuoteSAGE - Free Report) to co-develop zuranolone in depression and movement disorders. Biogen and Sage Therapeutics expect to file a single new drug application (NDA) seeking approval of zuranolone for the treatment of both major depressive disorder (MDD) and PPD. The submission of this single NDA is expected to be completed in the second half of 2022 to seek a priority review of the filing.

The BLA for the anti-amyloid beta antibody candidate, lecanemab to treat early Alzheimer’s disease has been granted priority review by the FDA under the accelerated approval pathway. An FDA decision is expected by Jan 6, 2023

Last week, Biogen and partner Eisai announced that their large phase III confirmatory study, Clarity AD, on lecanemab (BAN2401) to treat early Alzheimer’s disease (early AD), has met the primary endpoint. The study showed that treatment with lecanemab in the early stages of Alzheimer’s disease reduces the rate of clinical decline on the CDR-SB scale by 27% compared to placebo. Clinical Dementia Rating-Sum of Boxes or CDR-SB is a numerical scale that measures the severity of symptoms of dementia. Based on data from the Clarity AD study, Eisai will seek full FDA approval for lecanemab. Eisai plans to file for traditional approval of lecanemab in the United States and submit regulatory applications in the EU and Japan by the end of the first quarter of 2023.

Aduhelm’s failure raised doubt over the mechanism of anti-amyloid beta antibodies. These antibodies target clearing the abnormal accumulation of Aβ protein in the brain. The accumulation of these sticky proteins is considered to be one of the main causes of Alzheimer’s disease. Biogen/Eisai believe the latest lecanemab Clarity AD study results prove the amyloid hypothesis.

Following the failure of Aduhelm, Biogen announced a set of near-term operational priorities to drive renewed growth and value creation over time. The initiatives are expected to result in significant cost savings annually. The savings are expected to be invested in strategic initiatives over time.

Biogen is focusing on R&D activities with the highest probability of success. The company can accelerate, terminate, divest or partner with certain programs while continuing to evaluate new internal and external opportunities within Biogen’s therapeutic areas of focus and adjacencies.

The company also plans to focus more on emerging international markets, especially China and certain markets in both Latin America and the Middle East, to boost growth.

Under its new restructuring plan, Biogen is also looking to re-invigorate growth in its biosimilars portfolio with its newly-approved drug, Byooviz (referencing Roche’s Lucentis), and four other biosimilar candidates in development. Byooviz was approved in the United States and Europe in 2021 and launched in the United States in July 2022. Byooviz is expected to be launched in international markets in early 2023. Its key phase IIII biosimilar pipeline candidates are SB15, a biosimilar of Regeneron’s Eylea, and BIIB800, a biosimilar of Roche’s Actemra.