Legal

What Types of Patents Are to Blame for Biosimilar Market Delays?

January 29th 2024

By Skylar Jeremias

Article

Although manufacturing patents tend to be the most common type of patent referenced in litigation regarding biosimilar development, other patents actually have a greater impact on delays for biosimilar market launches.

Eye on Pharma: Fresh Biosimilar Lawsuits; FDA to Review Ustekinumab, Denosumab Biosimilars

January 11th 2024

By Skylar Jeremias

Article

As Regeneron gears up for a legal battle with biosimilar competitors for its reference aflibercept, CareFirst files a lawsuit against Johnson & Johnson for restricting biosimilar ustekinumab competition; Celltrion and Accord BioPharma file with the FDA to approve their respective biosimilar candidates.

Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar

November 22nd 2023

By Skylar Jeremias

Article

Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).

House Committee Hearing Addresses PBMs, Anticompetitive Drug Pricing Tactics

September 23rd 2023

By Gillian McGovern

Article

The House Committee members examined pricing tactics by PBMs and how they are harming patients across the country.

Biosimilar Business News Recap: 3 Biosimilar Application Submissions; Roche Sues Biogen

July 26th 2023

By Skylar Jeremias

Article

Formycon and Celltrion announced the FDA submissions for their aflibercept biosimilars; the European Medicines Agency accepted a marketing authorization application for an ustekinumab biosimilar; and Roche filed suit against Biogen over a tocilizumab biosimilar.

Senator Reintroduces Biosimilar Red Tape Elimination Act

July 14th 2023

By Skylar Jeremias

Article

Senator Mike Lee (R, Utah) reintroduced the Biosimilar Red Tape Elimination Act to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

Roundup: Coherus Resolves AbbVie Dispute; Bio-Thera Solutions and Celltrion Expand Respective Partnerships

June 17th 2023

By Skylar Jeremias

Article

Coherus Biosciences and AbbVie agree to resolve a dispute regarding Coherus’ partnership with the Mark Cuban Cost Plus Drug Company and an adalimumab biosimilar, and Celltrion and Bio-Thera Solutions expand their respective partnerships to include more biosimilar products.

Amgen’s Stelara Biosimilar Delayed Until 2025 After Settling With J&J

May 29th 2023

By Skylar Jeremias

Article

Amgen has settled with Johnson & Johnson (J&J) over the former’s ustekinumab biosimilar referencing Stelara, delaying the projected launch of the candidate from late 2023 to January 2025.

The Increasing Access to Biosimilars Act of 2023 Introduced to Congress

March 29th 2023

By Skylar Jeremias

Article

The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.

Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges

February 7th 2023

By The Center for Biosimilars Staff

Article

Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.