FDA Law Blog: Biosimilars

JUNE 11, 2023

Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. However, given FDA’s prior announced policy, it is somewhat surprising that only 16% of pediatric labeling changes pursuant to BPCA and/or PREA between 2002 and 2019 were conducted under both the BPCA and PREA.

Labelling 40

Labelling Drug Development 40

PharmaShots

MARCH 29, 2023

Some companies accept the offered period and open doors to biological drugs or biosimilars. As of now, there are no the US FDA approved biosimilars available for Actemra. However, last August, Fresenius Kabi announced the US FDA's acceptance of its biosimilar BLA, bringing a potential candidate into the market before long.

Biosimilars 49

Biosimilars Diabetes Chemotherapy Immunization 49

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

The requirement for prior notice originates in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). “Prior notice” informs FDA about the products it can expect to be offered for import into the country. food supply and other food-related emergencies.

52

52

pharmaphorum

FEBRUARY 26, 2021

Weldon became the Chairman and CEO of J&J in 2002. But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics. billion the following February.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

pharmaphorum

DECEMBER 2, 2020

Since the turn of the millennium, Pfizer has embarked on a series of mega-mergers, gobbling up Warner-Lambert in 2000, Pharmacia and Upjohn in 2002, Wyeth in 2009, and Medivation in 2016. The deal seemed to be a precursor to Pfizer’s plans to separate its patent-protected medicines business from its off-patent portfolio.

Compounding 128

Compounding Vaccines Biosimilars Diabetes 128

PharmaShots

JUNE 28, 2023

In July 2002, Amgen acquired the rights to Enbrel as part of its acquisition of Immunex. Some of the alternative drugs for Enbrel include: Enbrel’s Biosimilars6 As Enbrel has a long journey in the market it is already facing competition from biosimilars in the US and other countries. and Canada. Enbrel Prescribing Information 3.

Biosimilars 40

Biosimilars Insurance Coverage and Processing Dosage Compounding 40

Safe Biologics

APRIL 25, 2023

Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and implementation of Medicare Part D, the program’s prescription drug benefit.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130

Safe Biologics

APRIL 25, 2023

Having served in the Department of Health and Human Services’ Office of the Secretary from 2002-2008, including two years as Associate Deputy HHS Secretary, I participated in the development and implementation of Medicare Part D, the program’s prescription drug benefit.

Drug Pricing 130

Drug Pricing Biosimilars Vaccines 130