The proposed aflibercept biosimilar is intended to treat ophthalmic disorders. This FDA submission follows the licensing agreement under which Fresenius Kabi will exclusively commercialize the ...

Fact: branded biologic drugs are consistently among the most expensive in our healthcare system. 1 Compounding this, chronic conditions – often treated with biologics – are becoming increasingly ...

A new guidance document issued by the FDA this week offers recommendations for how makers of prescription biosimilars and biologic reference products should approach promotional advertising and ...

Every day, I think about the patients waiting for medicines that could change, or even save, their lives. For them, access is not a statistic. It is hope, health, and a chance for a better future.

The biosimilar Hyrimoz showed similar flare rates to Humira, but 25% of patients experienced adverse events, mainly injection site reactions. Injection pain, linked to Hyrimoz's citrate content and ...

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...

Mark Cuban Cost Plus Drug Co. has added Starjemza, a biosimilar to Johnson & Johnson’s Stelara (ustekinumab), to its portfolio. The company, co-founded by billionaire entrepreneur Mark Cuban, is ...

Forbes contributors publish independent expert analyses and insights. Joshua Cohen is a Boston-based writer who covers health policy. Biosimilars is a biologic medication that is highly similar to an ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. In 2009, Congress created a regulatory pathway for ...

The U.S. FDA on Wednesday issued draft guidance that aims to accelerate the process for getting biosimilar drugs -- essentially generic versions of pricey biologic-based medicines -- to consumers. The ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...