Regulatory

ACI Panelists Discuss Misaligned Incentives in the Biosimilars Market

July 15th 2021

By Tony Hagen

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

Axinn IP Chair Provides Analysis of Biden Biosimilars Initiative

July 14th 2021

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

Study: Medicare's Lost Savings Due to Delayed Adalimumab Biosimilar Entry

July 12th 2021

By Tony Hagen

Medicare lost out on over $2 billion in savings as adalimumab biosimilars were sidelined by patent restrictions, said investigators who recommended patent reforms.

Amgen US Biosimilar Trends Report Highlights Price Discounts

July 10th 2021

By Tony Hagen

Biosimilars are launching at significant discounts to reference products and capturing increasing market share, according to an Amgen report.

Panel Discusses Generic, Biosimilar Marketplace Sustainability

July 9th 2021

By Tony Hagen

Following the release of a whitepaper on sustainable generics and biosimilars markets, members of a trade association discussed concerning trends for the industry.

IGBA Takes Aim at Pricing Pressure and Post–COVID-19 Protectionism

July 8th 2021

By Tony Hagen

In a white paper, the International Generic and Biosimilar Medicines Association (IGBA) describes industry dynamics that it says affect market sustainability and patient access.

Bioeq Signs Another Marketing Deal for Ranibizumab Candidate

July 7th 2021

By Tony Hagen

Ahead of receiving regulatory approval for a "wet" age-related macular degeneration biosimilar candidate, a broad-based commercialization deal is inked.

Gan & Lee Insulin Biosimilar Candidates Demonstrate Biosimilarity in Trials

July 6th 2021

By Tony Hagen

Insulin aspart, lispro, and glargine biosimilar candidates referencing NovoRapid, Humalog, and Lantus demonstrated bioequivalence in trial data presented at the Scientific Sessions of the American Diabetes Association.

Alvotech's Ustekinumab Candidate Reaches Clinical Trial Milestone

July 6th 2021

By Tony Hagen

AVT04 (ustekinumab) if approved would be targeted at an estimated $7.7 billion market for the reference product, Stelara.

Leading Biosimilars Headlines From June 2021

July 5th 2021

The Center for Biosimilars® provided news and insight during June 2021 in the form of interviews with key opinion leaders and coverage of major events. Catch up on what you missed.