Biosimilar International Business Roundup: May 2020

As the coronavirus disease 2019 (COVID-19) pandemic continues to spread and hamper the pharmaceutical industry, international biosimilar companies have pushed forward, refusing to slow down. They continue to make deals, seek approvals, and conclude clinical trials.

Partnerships and Deal Making

Early in May, after settling a patent dispute with innovator company, Genentech, Teva Pharmaceutical Industries, based in Israel, and Celltrion Healthcare, based in South Korea, announced a broadening of indications for their rituximab biosimilar (Truxima) to include rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The 2 companies also expressed that they keep the product’s discount from the reference product (Rituxan) at 10%, despite the recent arrival of Pfizer’s competing rituximab biosimilar (Ruxience), which was offered at a 24% discount.

Gedeon Richter of Germany announced the $16.5 million purchase of a tocilizumab biosimilar (LusiNEX) developed by Taiwan-based Mycenax. The biosimilar is being tested in a phase 1 trial as a potential treatment of COVID-19.

Eye-health products company Bausch + Lomb (Canada) secured the commercialization rights of STADA Arzneimittel AG’s (Germany) ranibizumab biosimilar (Xlucane), currently under development for the US and Canadian markets. The biosimilar references Lucentis, which has patents expiring this year in the United States and in 2022 in Europe.

Additionally, British-Swedish company AstraZeneca made a brief statement announcing the purchase of a brazikumab biosimilar from Ireland-based Allergan for commercialization. The transfer was required for Allergan to qualify for a merger with AbbVie. In the statement, AstraZeneca did not comment on rising concerns over whether it would work to uphold a competitive marketplace for IL-23 inhibitors such as brazikumab, which was a concern of the Federal Trade Commission in approving the Allergan/AbbVie merger.

One Step Closer to Launch

Many companies moved further along in the approval process during May, including France-based Sanofi, which received a recommendation for market authorization from the Committee for Medicinal Products for Human Use in Europe for its insulin aspart biosimilar currently awaiting approval from the European Commission.

Germany-based Fresenius Kabi’s pegfilgrastim biosimilar (MSB11455) had a big month, as clinical trials findings demonstrated a similar safety and immunogenicity profile to the reference product. The biosimilar company filed a biologics license application with the FDA.

Fresenius Kabi also signed an agreement with German company medac for the commercialization of its adalimumab biosimilar (Idacio) in Germany.

AryoGen Pharmed (Iran), Alvotech (Iceland), and Samsung Bioepis (Republic of Korea) announced equivalency results to reference products for 3 biosimilars from phase 3 clinical trials: bevacizumab (BV1040V) referencing Avastin, adalimumab (AVT02) referencing Humira, and ranibizumab (SB11) referencing Lucentis, respectively.

Samsung Bioepis also reported clinical trial data from 3 studies that demonstrate equivalency for its trastuzumab biosimilar (Ontuzant), which launched on the US market in April.

Celltrion sought approval for its adalimumab biosimilar (CT-P17) from the European Medicines Agency in hopes of getting into the increasingly competitive European adalimumab market. An immediate market launch is planned once it receives approval.

JHL Biotech of Taiwan initiated a phase 1 clinical trial for its denosumab biosimilar (JHL 1266), a candidate to treat bone loss. The company said the 3-arm study is being conducted in Australia and described it as pivotal for approval.

In Other News

COVID-19 has delayed product approvals and launches, but Republic of Korea—based Daewon Pharmaceutical powered through, launching its first product, Terosa, a teriparatide biosimilar, after entering into a domestic sales agreement with Richter-Helm Biotec, which itself is a joint venture between Helm (Germany) and Gedeon Richter (Hungary).

COVID-19 forced the postponement of Formycon’s (Germany) annual meeting from May to December. The company said the postponement did not affect the publication of its 2019 fiscal year financial statement, which was published as planned on May 18, 2020.

Lastly, India-based Biocon said its subsidiary Biocon Biologics has received European Union Good Manufacturing Practice certification for multiple manufacturing facilities to produce biosimilars in Bengaluru, India.