biosimilars

Hyderabad-based Aurobindo has put the Indian market in its sights with the $22.6 million acquisition of the domestic formulations business of Veritaz, Aurobindo announced Monday. Veritaz boasts around 40 brands in the acute and critical care therapeutic segments and is also headquartered in Hyderabad.

The acquisition will serve as a “launch pad for marketing biosimilar and other products in India,” Aurobindo said in its press release.

Viatris will offload its biosimilars business to Biocon Biologics for up to $3.3 billion in cash and stocks and take an ownership stake in the Indian firm, the Pennsylvania-based company announced Monday.

The investment will give Biocon access to Viatris’ portfolio in diabetes, immunology, oncology and other noncommunicable diseases and to its “robust commercial engine” in Europe and the U.S., a statement from the Bengaluru-based company said.

Meanwhile, Viatris—which launched…

Samsung Biologics is buying out Biogen's nearly 50% stake in their Samsung Bioepis biosimilars joint venture for $2.3 billion, the companies announced last week.

The JV has launched five biosimilars to date, with four more currently in Phase 3, according to a Samsung press release.

The Wall Street Journal said Massachusetts-based Biogen might use the proceeds for new acquisitions "as it grapples with the fallout over Aduhelm," its controversial Alzheimer's treatment.

The Clinton Health Access Initiative (CHAI) and the American Cancer Society (ACS) announced Monday that Biocon Biologics will join their Cancer Access Partnership (CAP), which aims to increase access to cancer treatments in low- and middle-income countries in Africa and Asia.

The addition of the Bangalore-based company—“India’s largest biopharma,” according to Biocon’s website—and an expanded portfolio of biosimilars from Pfizer will allow the partnership to offer affordable…

Market research firm IQVIA released a report last week saying that the availability and use of biosimilars in the United States has been accelerating: as a result, the country is on track to reduce spending on medicines by over $100 billion over the next five years, according to the research.

The report found that 19% of the $211 billion biologics market is already exposed to biosimilar competition, giving U.S. patients and payers lower-cost options—with the potential for future…

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The U.S. FDA and the U.S. Federal Trade Commission released a joint statement Monday announcing a collaborative effort to “support appropriate adoption” of biosimilars. Calling a competitive biologic marketplace “essential” to improving access to medicines, the statement outlined a four-point program to promote competition, facilitate access to samples for biosimilar manufacturers, address “false or misleading communications” and review patent settlement agreements.

The FDA also…

WHO announced today that it has awarded Samsung Bioepis’ trastuzumab its first biosimilar prequalification. According to the press release, the copycat breast cancer monoclonal antibody is “generally 65 percent cheaper” than Genentech’s Herceptin while treatment outcomes were “comparable” to the originator in efficacy, safety and quality.

WHO announced earlier this month that it has signed a memorandum of understanding with the Geneva-based International Generic and Biosimilar Medicines Association to promote access to medicines.

According to the WHO press release, the agreement “will facilitate cooperation between the two organizations to reduce the burden of clinical trials for biosimilars, speeding up registration and increasing access.”

A U.S. appeals court has rejected Allergan's attempt to use a Native American group’s legal immunity to avoid a patent challenge.

Allergan signed an agreement with the Saint Regis Mohawk Tribe in September 2017 granting the tribe ownership of all its U.S. patents for its dry-eye treatment Restasis in an effort to block legal action by generic rivals Mylan and Teva (because tribes are sovereign nations under U.S. law).

The court ruled last week, however, that this type of legal…

Germany’s Merck KGaA announced this week that it will invest $47 million to build new facilities across Asia over the next two years. According to the company’s press release, the projects will include new manufacturing and distribution sites in South Korea and India expected to come into operation in 2019, and a single-use site for biosimilars in China that will become operational this year.