FDA Law Blog: Biosimilars

FEBRUARY 4, 2025

In the eleven years from 2009 to the end of 2019, FDA awarded 11 tropical disease PRVs for the development of therapies for diseases such as malaria, tuberculosis, dengue, and river blindness. See Table 1. While lapse of this program may raise concerns about the end of the Tropical Disease PRV, such a result is highly unlikely.

Vaccines 52

Vaccines 52

PharmaShots

APRIL 13, 2023

2009 was a challenging year for multinational companies due to the recession and currency fluctuations Johnson & Johnson's performance graph declined by 2.9% Despite a challenging year, Johnson & Johnson acquired Cougar and Elan Pfizer's 2009 performance was significant as compared to 2008 with the addition of Wyeth.

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

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. Like most pharma companies of its size, Pfizer has faced its fair share of controversy as one of the most well-known drugmakers in the world.

Compounding 128

Compounding Vaccines Biosimilars Diabetes 128

pharmaphorum

FEBRUARY 26, 2021

The litigation was settled in 2009, when Boston Scientific agreed to pay $716 million in September and an additional $1.73 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.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

pharmaphorum

JANUARY 5, 2021

Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at. These changes are likely to reduce only slowly in the Vaccine+ environment, and will not be entirely reversed.

Hospitals 105

Hospitals Vaccines Pharmaceutical Companies Pharmaceutical Companies 105

pharmaphorum

FEBRUARY 5, 2021

The FDA has developed in line with the life sciences industry during Woodcock’s time and has kept pace with development of innovations such as cancer cell therapies, biosimilars and digital therapeutics. Hahn had to fight off pressure from the Trump administration to approve Pfizer’s vaccine early.

Vaccines 119

Vaccines Biosimilars Labelling 119