article thumbnail

Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

Explain the FDA Approval Process Many patients are unaware of the rigorous approval process generic drugs must undergo. Educate them about the FDA’s role in ensuring the safety and efficacy of generic medications. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research Sources cited: U.S.

article thumbnail

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

FDA Approves Merilog, First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

Drugs.com

Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus. WEDNESDAY, Feb. 19, 2025 -- The U.S. Merilog is a rapid-acting human.

article thumbnail

FDA Approves First Rapid-Acting Insulin Biosimilar for Patients With Diabetes

Drugs.com

Food and Drug Administration has approved Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.Merilog is a rapid-acting human. WEDNESDAY, Feb. 19, 2025 -- The U.S.

article thumbnail

Humira biosimilar from Alvotech, Teva wins FDA approval on third attempt

BioPharma Drive: Drug Pricing

The companies didn’t reveal their planned price for Simlandi, which will be the 10th Humira copycat to reach the U.S.

article thumbnail

Even in “Unprecedented” Times, There is Precedent

FDA Law Blog: Biosimilars

The HHS Secretary intervened in an FDA approval decision. The court ruled the agency’s action was arbitrary and capricious and entered a mandatory injunction ordering FDA to make the drug available. Hawaii and related cases.

article thumbnail

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. for the treatment of diabetes.