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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.

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FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

FDA Law Blog: Drug Discovery

The benefits of the CNPV are not limited to FDA review of marketing applications. Such benefits during the IND phase include “enhanced communication” and “prompt responses.” As described in a 2022 FDA analysis , the median time-to-approval from submission for RTOR applications was 3.3 months, ranging from 0.4

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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.

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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.

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Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA

The Pharma Data

Submission supported by comprehensive analytical and clinical data from new Phase I bridging pharmacokinetics study Adalimumab’s high-concentration 100 mg/mL formulation aims to provide an enhanced yet familiar experience for patients Submission builds on Sandoz’ well established biosimilar immunology portfolio in Europe.

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Analysis Life Sciences Thank You Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach

Agency IQ

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products.

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FDA Approves Updated ADUHELM™ Prescribing Information to Emphasize Population Studied in Clinical Trials

The Pharma Data

With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.