FDA Law Blog: Biosimilars

APRIL 8, 2025

OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

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Documentation Labelling Drug Development 141

Express Pharma

MARCH 16, 2025

First, advanced research and development (R&D) and biologics will be critical. To move from generics to novel drug development, Indian companies must invest heavily in R&D for innovative therapies like biosimilars, cell and gene therapies, and specialty drugs. and Europe.

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Biosimilars Insurance Coverage and Processing Pharmaceutical Companies Pharmaceutical Companies 98

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

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Biosimilars Drug Pricing Drug Development 130

FDA Law Blog: Biosimilars

DECEMBER 13, 2023

Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.” GeMDAC’s mandate is to advise the Agency on these complicated issues in this challenging area of medical product development. irritable bowel syndrome, primary biliary cholangitis).

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Drug Development 59

Safe Biologics

OCTOBER 10, 2023

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection. Tyruko (natalizumab-sztn) is the 42nd biosimilar approved by the U.S. – View clip.

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Biosimilars Drug Pricing Drug Development 130

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Biopharmaceutical Research & Development: The Process Behind New Medicines. 23 April 2013.

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Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

Safe Biologics

SEPTEMBER 11, 2023

Contrary to what many believe, under Part D, drug price negotiations do occur- they are conducted by pharmacy benefit managers (PBMs), and the law specifically forbid government interference in price-setting or formulary selection.

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Drug Pricing Biosimilars Vaccines Drug Development 150