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FDA, biosimilar and diabetes

FDA approves subcutaneous Merilog for glycemic control in diabetes

The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog (insulin-aspart-szjj, Sanofi-Aventis U.S.) was approved as biosimilar to Novolog (Novo Nordisk) for improving blood sugar control for individuals with the condition,

Business Insider · 16h

FDA approves Sanofi biosimilar product for treatment of diabetes

The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric

The Financial Express · 5h

FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment

The U.S. Food and Drug Administration (USFDA) on Friday approved Merilog as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.

Medscape · 12d

FDA Approves Third Tocilizumab Biosimilar

The biosimilar will be available in both subcutaneous and intravenous formulations and has nearly all the same indications as the originator tocilizumab, Actemra.

Seeking Alpha on MSN · 15h

Sanofi gets FDA approval for NovoLog insulin biosimilar

Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children with diabetes mellitus.

MedPage Today14h

FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes

The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and ...

Manufacturers Challenge CMS’s Definitions of ‘QSSD’ and ‘Bona Fide Marketing'

Drug manufacturers remain steadfast in their efforts to challenge the constitutionality of the Inflation Reduction Act’s mandatory price ...

11don MSN

Pharma distributor, generic drug trade groups express concern over tariffs

Trade groups representing pharma distributors and generic/biosimilar industries express concerns over potential tariffs on ...

Biogen CEO hails quartet of new launches as multiple sclerosis competition weighs on 2025 guidance

While the continued erosion of Biogen’s multiple sclerosis franchise and weaker-than-expected 2025 guidance doesn’t seem to ...

8d

Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions

While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.

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