Biosimilars Development Updates


  • According to a press release, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70% and to establish a purification system that would allow parallel manufacturing of multiple drugs at the Novartis Pharma S.A.A. Biotechnology Center in Huningue, France. In the press release, Jacobs Engineering said that the expansion project is worth US$100 million and is expected to be completed in four years.
  • FierceBiotech reported on August 8, 2016 that Pfizer has ended its deal with Pfenex (PFNX) relating to the development of PF582, a biosimilar candidate to Genentech’s Lucentis (ranibizumab), which is a monoclonal antibody fragment to treat wet age-related macular degeneration (AMD).
  • reported that at the meeting of the American Society of Retina Specialists on August 13, 2016, Dr. Alay Banker presented results from a randomized clinical trial in India, showing that a new batch of Razumab, a biosimilar to Genentech’s Lucentis, appears to be safe and efficacious compared to the company’s first three batches of the drug. In this trial Razumab did not result in the high incidence of inflammation as was observed with the drugs produced in the first three batches.
  • On August 10, 2016, the Wall Street Journal reported that Samsung BioLogics Co. (Korea) is planning to raise US$2.5 billion through an initial public offering (IPO) on the Korea Composite Stock Price Index (KOSPI) in August 2016. According to the company’s press release on April 28, 2016, the IPO was planned with an aim to “strengthen its presence in the rapidly growing global biopharmaceutical market” and, by 2018, “to become the world’s largest contract manufacturing organization (CMO) for biologics, with a total production capacity of 360,000 liters.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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