2025 Biosimilars Drug Pricing 
STAT
SEPTEMBER 23, 2022
Market share is often held up as the most relevant metric for the success of a biosimilar class. I believe there are other metrics, like cost savings or signs of greater patient access, that should also be used to define biosimilars’ successes or failures. the first biosimilar was launched in September 2015. In the U.S.,
STAT
AUGUST 30, 2023
government’s initial approach to negotiating drug prices could discourage cheaper biosimilar versions of more complex pharmaceuticals that eat up a high portion of total Medicare spending , Bloomberg Law explains. Amgen and J&J reached an agreement in May to allow a biosimilar for Stelara no later than Jan.
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Big Molecule Watch
NOVEMBER 6, 2023
On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab). WEZLANA is the first product to be approved as a biosimilar to STELARA.
FDA Law Blog: Biosimilars
MARCH 12, 2025
The American Conference Institutes 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S.
FDA Law Blog: Biosimilars
MARCH 18, 2025
Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension. On March 13, 2025, the Federal Circuit ventured into the world of reissued patents and PTE. (
Big Molecule Watch
JANUARY 14, 2025
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last years recap of 2023 , Regenerons litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Big Molecule Watch
AUGUST 25, 2023
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.
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