Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available ...

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

Introduction of biosimilars for the rheumatology drug adalimumab, whose original branded version Humira has long been a blockbuster, appears to have led to a dramatic drop in net spending for these ...

Biologic drugs have improved how doctors treat serious illnesses. Instead of being made from chemicals, biologics are made from organic materials and grown in living cells. Biologic drugs are used ...

Over the last decade-plus, China has become a booming biopharma innovator thanks in part to a big boost from its government. Now the question is, can its neighbor to the south, India, make a similar ...

Key market opportunities in oncology biosimilars include leveraging AI for streamlined clinical trials and precision medicine ...

Enzeevum, a biosimilar to Eylea, is approved in Canada for multiple retinal conditions, expanding treatment options for ophthalmologists. Biosimilars may offer cost-effective alternatives, potentially ...

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s agenda since he took office in January. He has taken a number of steps, including striking deals with ...

India is set to become a global biopharmaceutical manufacturing hub. Finance Minister Nirmala Sitharaman announced a ...

The FDA recently designated Yuflyma as "interchangeable" with the popular biologic Humira for the treatment of Crohn's disease and ulcerative colitis, two types of inflammatory bowel disease (IBD), ...