July 4th 2021
The Supreme Court’s ruling in the Affordable Care Act (ACA) case appears to have saved the biosimilars approval pathway, but do the plaintiffs have other avenues by which to bring another challenge?
July 1st 2021
By Tony Hagen
The BIOSIM Act would increase the add-on payment for use of a biosimilar, thereby incentivizing practitioners to use these products more often, according to proponents of the bill.
June 23rd 2021
Pay-for-delay settlements between drug companies are better regulated than in the past and are in danger of being overregulated, one panelist said.
June 22nd 2021
Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.
June 18th 2021
Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market.
June 17th 2021
A technicality—inability to demonstrate harm—frustrated plaintiffs whose case threatened to sink not just the Affordable Care Act but also the Biosimilars Price Competition and Innovation Act (BPCIA), the pathway for biosimilars approvals.
The Mississippi attorney general takes on major insulin producers and pharmacy benefit managers in a suit alleging a massive pricing scheme to gouge patients and payers.
June 10th 2021
The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.
June 2nd 2021
Celltrion announces the launch timing for its much anticipated high-concentration formulation of adalimumab and presents trial data supporting equivalence to the reference product.
June 1st 2021
Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.
