Biogen recently announced Food and Drug Administration (FDA) approval of its new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS). This new formulation will enable Biogen to expand its MS portfolio, while also reducing the side effects from the subcutaneous way of administration of Plegridy. However, market uptake will be limited by the progressive decline in reliance on interferon (IFN) agents as the gold standard of treatment, says GlobalData, a leading data and analytics company.

Alessio Brunello, Managing Pharma Analyst at GlobalData, comments: “Patients are continuing to switch to oral disease modifying therapies (DMTs) and anti-CD20 mAb therapies such as Roche’s Ocrevus (ocrelizumab) and Novartis’ Kesimpta (ofatumumab) due to their improved convenience. Furthermore, the launch of efficacious oral and convenient monoclonal antibody (mAb) injectable DMTs will steal further potential patients from Plegridy.”

Despite this, IFNβ will continue to play a critical role in the treatment algorithm for MS. GlobalData forecast Plegridy to generate $334m in sales revenue globally in 2026. In addition, the IM version of Plegridy was approved in December 2020 from the European Marketing Authorization (EMA).

Biogen’s portfolio for MS has been affected in the past year due to loss of patent protection and in revenues of its blockbuster drug Tecfidera (dimethyl fumarate). Biogen reported sales of $3.84bn in 2020 and GlobalData forecast that in 2026 Tecfidera will generate $1.12bn due to generic competition. The decline from 2019 is due also to the launch of second generation S1P receptor modulators, namely Novartis’ Mayzent (siponimod fumerate) in March 2019, Celgene’s Zeposia (ozanimod) in March 2020 and Janssen’s ponesimod (currently in pre-registration in the US and EU). The launch of Biogen’s Vumerity (diroximel fumarate) alongside of Roche’s Ocrevus, Novartis’ Kesimpta and other anti-CD20 mAb pipeline assets are expected to steal some market share from Tecfidera.

Brunello adds: “In an effort to address the Tecfidera patent expiration and the increasing competition in the MS landscape, Biogen launched its new drug Vumerity in 2019 in the US with the hope that Vumerity could potentially differentiate itself from Tecfidera as it demonstrated better GI tolerability in the Phase III head-to-head trial against Tecfidera. Therefore, patients who have tolerability issues using Tecfidera were likely to switch to Vumerity. However, the uptake in the US has not been as robust as expected and Vumerity generated sales of just $64m in 2020.”