Biosimilars Business Roundup: August 2023

After a busy July, August brought hope for the biosimilars industry’s future, with the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and several analyses about the health of the market.

Policy and Regulatory Updates

The end of August brought the biggest news, with the FDA approval of the first natalizumab biosimilar, Tyruko (natalizumab-sztn). The product referencing Tysabri is the first biosimilar treatment for multiple sclerosis. The drug can also be used in the treatment of patients with Crohn disease.

Tyruko was developed by Polpharma Biologics, a Poland-based manufacturing and development company, and will be marketed globally by Sandoz as part of a 2019 commercialization agreement. The approval is the fourth FDA approval for a biosimilar in 2023.

Additionally, the list of the first 10 drugs chosen for Medicare price negotiation under the Inflation Reduction Act (IRA) was announced, including 2 originator biologics that are expected to have biosimilar competition within the next decade: Stelara (ustekinumab) and Enbrel (etanercept). The full list included a range of drugs in the immunology, hematology, cardiology, oncology, and diabetes spaces.

To be eligible for negotiation, medications must have a high likelihood that they will not face biosimilar or generic competition in the next 2 years and have to have been on the US market for at least 9 years for small molecule drugs and 13 for biologics. Although Enbrel has 2 FDA-approved biosimilars and Stelara has a few biosimilar competitors coming down the pipeline, etanercept and ustekinumab biosimilars aren’t expected to launch until 2029 and 2025, respectively.

Quarterly Expense Reports

Biocon’s earnings report for the quarter showed a 106% growth in sales compared with the same quarter the previous year, which was largely attributed to the completed acquisition of Viatris’ biosimilar portfolio as well as market share growth for products marketed in the United States and European Union.

As part of the Viatris acquisition, Biocon gained the rights to biosimilar products in over 70 countries, and Biocon confirmed that its next steps are to integrate the business in North America by the end of the second quarter of fiscal year 2024.

The company collected $423 million in consolidated revenue, a 59% year-over-year increase from the same quarter the previous year. Biosimilar accounted for 57% of the revenue, generics made up 20%, and the other 23% was attributed to research services.

Similarly, STADA Arzneimittel saw double-digit growth in the first 6 months of 2023, foreshadowing record-breaking profits by year-end. Overall sales increased by 16% from the same period in 2022, reaching €2.1 billion ($2.3 billion). Earnings increased by 30% to €509 million ($555 million). STADA’s portfolio has 6 biosimilars available in several global markets, including the European Union, United Kingdom, and United States.

On the flip side, despite global increase in sales for Amjevita, Amgen’s adalimumab biosimilar, US sales for the product have dropped by 63% since its January 2023 market introduction. Overall profits for Amgen were up 6% from the second quarter of 2023 vs the same quarter in 2022, totaling $7.0 billion.

Market Analyses and Calls for Development Streamlining

A paper authored by 4 prominent voices in the biosimilar space from different pharmaceutical companies weighed in on ways that biosimilar development could be streamlined without impacting clinical outcomes for patients.

The authors made several suggestions for policy changes to improve development efficiency and lower costs, including limiting clinical studies to pharmacokinetic evaluations and removing the requirement for multiple-switch studies to obtain US interchangeability designations.

In a recent opinion piece, Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, predicted greater adoption, accessibility, and provider acceptance of adalimumab biosimilars in the future, saying that these biosimilars have the potential to “transform” the US health care industry.

So far, the United States has welcomed 8 adalimumab biosimilars to the market in 2023, and projections have shown that biosimilars overall could generate $38.4 billion in health care savings between 2021 and 2025, half of which is expected to come from the adalimumab market.