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January 28, 2022
Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.
November 12, 2021
The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies.
November 01, 2021
The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.
October 15, 2021
The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.
October 01, 2021
Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.
September 27, 2021
Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.
September 21, 2021
The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.
September 01, 2021
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
August 01, 2021
Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.
May 18, 2021
The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.