Regulatory

Upcoming Biosimilars and the Impact of IRA: Key Takeaways From Jeffrey Casberg

September 3rd 2024

By Cameron Santoro

Jeffrey Casberg discusses key upcoming biosimilars and specialty drugs, the impact of the Inflation Reduction Act on drug pricing, and the evolving role of pharmacy benefit managers in the market.

BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit

August 26th 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.

CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel

August 19th 2024

By Skylar Jeremias

Article

CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.

FDA Approves Biosimilar Enzeevu for Eye Conditions

August 12th 2024

By Skylar Jeremias

Article

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

Manitoba Adopts Biosimilar Switching Policy

August 7th 2024

By Skylar Jeremias

Article

Manitoba’s new policy means that all 10 Canadian provinces now have an initiative to boost biosimilar adoption and savings by transitioning patients on reference agents to biosimilar options.

Learning the Lingo of Biologics and Biosimilars Is Critical

July 31st 2024

By Jeannette Y. Wick, RPh, MBA, FASCP

Article

The number of FDA-approved biologics has exploded, and biosimilars are making their mark.

FDA Approves Epysqli as Second Soliris Biosimilar

July 22nd 2024

By Skylar Jeremias

Article

The FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh), marking the second US approval for a biosimilar referencing Soliris (eculizumab).

Ahzantive Receives FDA Approval as New Eylea Biosimilar

July 1st 2024

By Skylar Jeremias

Article

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration.

FDA Approves Samsung Bioepis’ Pyzchiva, a Biosimilar to Stelara

July 1st 2024

By Skylar Jeremias

Article

Pyzchiva (ustekinumab-ttwe) is the third ustekinumab biosimilar to receive approval for the American market. It was also approved with interchangeability.

BioRationality: FDA Removes Additional Testing for Interchangeable Status of Biosimilars

July 1st 2024

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, champions the FDA's updated guidance to remove switching study data for companies seeking to obtain an interchangeability designation for their biosimilars.