Biosimilar Business Roundup: April 2020

Although the coronavirus disease 2019 (COVID-19) pandemic put a damper on activities, the month of April saw steady business developments, from biosimilar approvals and launches to strong earnings reports for biosimilars and even regulatory approval for a biosimilar manufacturing site.

Earnings Reports

With a growing portfolio of biosimilars, Novartis saw a 31% increase in biopharmaceutical net sales for the first quarter of 2020, despite the pandemic. Novartis develops and retails biosimilars through its Sandoz arm. Sandoz’ net sales for the quarter were $2.5 billion, up 9%.

Pfizer reported that biosimilar and generic competition are expected to hurt its originator brands this year to the tune of $2.4 billion in lost revenue, although it reported that its biosimilars portfolio is generating strong double-digit revenue growth.

Biogen reported biosimilars earnings of $219 million for the first quarter, up 25% compared with the year-ago comparable quarter, an increase of $44 million. The company said its anti—tumor necrosis factor (TNF) biosimilars have been used to combat COVID-19 and it attributed $15 million of first-quarter earnings to this.

Amgen reported that overall product sales increased 12% globally, and this included results for its bevacizumab and trastuzumab biosimilars, but the company said product revenues were offset by competition from other biosimilar and generic makers.

Business Development

Shanghai-based Henlius Biotech said its Xuhui manufacturing facility has met European standards for production of its trastuzumab biosimilar candidate, which the company said is “a passport” for potential commercialization across the globe. Anticipating approval of its trastuzumab biosimilar HLX02 from the European Medicines Agency, the company has put global commercialization plans into place.

Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad. In an interview with The Center for Biosimilars^®, Roman Drai, MD, PhD, deputy director and head of clinical operations for Geropharm, said the barriers to biosimilar marketing in the United States are slowly diminishing, although in Europe the business opportunities are more robust.

Product Launches and Approvals

On April 2, Pfizer announced that the European Commission had approved its rituximab monoclonal antibody, Ruxience, for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other disorders.

On April 15, Merck announced that it was launching its Ontruzant trastuzumab biosimilar in the US market. This became the third trastuzumab biosimilar to arrive on the US market in 2020, making the market more crowded for competitors. In this venture, Merck is the commercialization partner of Samsung Bioepis.

Sang-Jin Pak, MD, executive vice president of Samsung Bioepis’ Commercial Division, in an interview with The Center for Biosimilars^®, said despite the growing competition for trastuzumab products, there is likely to be ample business opportunity.

Also in mid-April, Mylan and Biocon launched a pegfilgrastim biosimilar (Fulphila) in Australia, and on April 28, the companies announced they had launched the same product in Canada, also. The agent helps to shorten the duration of severe neutropenia and reduce the incidence of infections, as manifested by febrile neutropenia.

A comparison of biosimilar launches and approvals in the first quarter of 2020 with those in the comparable year-ago quarter showed more launches than FDA approvals in the just-finished quarter. Experts have said launch horizons for approved biosimilars can be expected to be pushed back 6 months or more, based on the complications presented by COVID-19 and the difficulties of marketing products in an environment where sales representatives cannot meet face-to-face with providers and other key individuals.

Several additional biosimilar launches could occur this year, experts said during the Academy of Managed Care Pharmacy (AMCP) virtual meeting in April. Those new products could include a pegfilgrastim, 2 bevacizumabs, and a rituximab.

COVID-19’s Effect on Biosimilar Business

An expert presenting for the AMCP virtual meeting explained that COVID-19 notwithstanding, it’s important to keep the biosimilar pipeline active because of the important savings and access benefits these agents offer. “We are going to need specialty generics and biosimilars,” said Douglas M. Long, MBA, vice president of Industry Relations for IQVIA.

Finally, the FDA’s new focus on COVID-19 and the quarantines imposed on much of the developed world have pushed digital and remote marketing of pharmaceutical products into high gear, and this bodes well for a transformation in the way biosimilars are marketed in the United States, Jamie Peck, managing director of iON, said in an interview with The Center for Biosimilars^®.