Tony Hagen is senior managing editor for The Center for Biosimilars®.
Biosimilars will be the cornerstone for a leap into biologics development and commercialization, according to the CEO of Prestige Biopharma. Also, Innovent Biologics reaches a marketing agreement.
On the eve of its February 2021 public offering, Prestige Biopharma, of Singapore, reemphasized its focus on developing biosimilars. Company CEO So-yeon Park stated that Prestige aims to develop and market biosimilars to establish a steady stream of operating capital before moving on to develop other types of drugs.
“Developing new drugs is very profitable but is accompanied by lots of risks,” Park was quoted as saying by Republic of Korea biopharmaceutical press. “With this in mind, we have decided to focus on developing low-risk biosimilars for the time being.”
Park predicted significant growth for biosimilar companies in the near future based on the number of blockbuster biologic originator drugs that are losing patent protection. The company is developing a trastuzumab biosimilar (HD201), and phase 3 clinical trials have been wrapped up. The company has applied for approval in the European Union and plans to file a biologics license application in the United States.
Prestige also is working to complete phase 3 clinical trials for HD204, a biosimilar for bevacizumab (Avastin), with plans to launch in 2022, according to the Korean press report. In addition, the company has an adalimumab biosimilar in development (PBP1502).
Although biosimilars are central to its early growth strategy, the company is developing a pancreatic cancer antibody drug, PBP1510, a monoclonal antibody that targets pancreatic adenocarcinoma up-regulated factor (PAUF). In June 2020, the FDA granted an orphan drug designation to the first-in-class anti-PAUF drug candidate. Similarly, the European Medicines Agency in October 2020 granted a positive opinion for an orphan drug designation for the agent. Orphan status guarantees a lengthy period of product exclusivity, assuming the drug candidate is approved by regulators.
Innovent Biologics, a Suzhou, China–based company, said it has reached an agreement with PT Etana Biotechnologies Indonesia to comarket Innovent’s bevacizumab biosimilar (Byvasda) in Indonesia.
“We are confident that pairing Etana’s commercial expertise in the local Indonesian market with Byvasda’s clinical profile will further accelerate out mission, benefitting patients globally," said Blake Salisbury, MBA, vice president of Business Development of Innovent, in a statement.
Byvasda received previous approval from Chinese regulators for the treatment of non–small cell lung cancer, metastatic colorectal cancer, and adult recurrent glioblastoma. In January 2020, Innovent contracted with Coherus BioSciences to commercialize the biosimilar in the United States and Canada, after it obtains regulatory approval in those markets. Innovent has yet to obtain Indonesian regulatory approval for Byvasda.