As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

Biocon recently unveiled three new biosimilar oncology assets to its R&D pipeline —trastuzumab/hyaluronidase (Herceptin ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Ondibta is approved for the treatment of diabetes mellitus in adults, adolescents and in children aged two years old and ...

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

As cancer cases climb steadily across India, lower-cost biosimilars like Tishtha could reshape access to life-saving ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo (Reuters) -The U.S. Food and ...

Opportunities in the market include the rising demand due to increased clinical trials & biosimilar developments, especially in oncology and immunology. Advanced cold chain logistics and AI-driven ...

Samsung Epis Holdings, the new holding company for Samsung Bioepis, is pursuing a bold expansion strategy focused on pipeline ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

According to multiple recent market analyses, the global API market is experiencing steady growth. One comprehensive forecast projects the global active pharmaceutical ingredient market to expand from ...

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...