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FDA’s response to coronavirus

In response to the coronavirus pandemic, the US Food and Drug Administration (FDA) has issued a comprehensive statement regarding effects on the supply chain and inspections of plants overseas.

Roche continues litigation in India and receives fine in Romania

Switzerland-based pharmaceutical giant Roche is continuing to pursue legal action in India over a trastuzumab similar biologic and has recently been fined in Romania for delaying the entry of biosimilars to the market.

New biosimilars partnerships from Alvotech and Biocon

Alvotech has formed an exclusive partnership with JAMP Pharma (JAMP) for the commercialization of its biosimilars in Canada, while Biocon has expanded its collaboration with Equillium to include Australia and New Zealand.

Amgen to buy out Japanese partner Astellas

US-based biotech giant Amgen has announced that it will dissolve its joint venture with the Japanese company Astellas in order to operate the unit independently. This means Astellas will become a wholly-owned Amgen affiliate.

Celltrion to build facility in China and increase new drug output

South Korean biotechnology company Celltrion has announced plans to build its first overseas factory in China. The company also intends to release one new biosimilar per year until 2030.

Merck to create spin off for women’s health and biosimilars

US pharma giant Merck is to create a spin-off company for its women’s health, biosimilars and legacy products, allowing the main company to focus on blockbuster cancer drug Keytruda (pembrolizumab).

US health insurers partner with generics maker Civica

The Blue Cross Blue Shield Association (BCBSA), a federation of health insurers in the US, has formed a partnership with generics manufacturer Civica Rx to reduce the costs of generic drugs.

Coherus signs licensing deal for bevacizumab biosimilar in the US

US-based Coherus BioSciences (Coherus) announced on 13 January 2020 that it had entered into a licensing agreement with Chinese biopharmaceutical firm Innovent Biologics (Innovent) for its bevacizumab product, IBI305.

Top 10 most read GaBI Online articles in 2019

It has once again been a busy year for biosimilars. One of the most important milestones for biosimilars in 2019 was the World Health Organization (WHO) pilot programme to prequalify rituximab and trastuzumab biosimilars. Other subjects of interest for biosimilars were US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, naming and regulation of biosimilars, as well as biosimilar guidance, uptake and switching.

Mundipharma and Samsung Bioepis partner for biosimilars in Hong Kong and Taiwan

Mundipharma announced on 13 January 2020 that it had entered into a partnership with Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) to commercialize four biosimilar candidates from Samsung Bioepis in Hong Kong and Taiwan.

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