2011 Biosimilars Documentation 
STAT
OCTOBER 23, 2024
Amgen will launch its biosimilar version of a blockbuster Regeneron Pharmaceutical drug for an eye disease following a U.S. regulators in 2011. The FDA still has to make a decision on whether to officially place semaglutide on the lists. appeals court ruling in its favor , Reuters writes. Last year, the drug generated $5.89
FDA Law Blog: Biosimilars
SEPTEMBER 11, 2023
Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Pharma in Brief
DECEMBER 3, 2023
This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations ( Regulations ), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators. For example: Reduced stay. Revised section 8 damages.
FDA Law Blog: Biosimilars
FEBRUARY 28, 2024
This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. In contrast , the two previous withdrawals, Makena in 2023 and Avastin in 2011, took 30 months and 11 months, respectively. All in all, the new expedited procedures took about 7 months from proposal to withdrawal.
European Pharmaceutical Review
JULY 4, 2024
2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.
FDA Law Blog: Biosimilars
MAY 11, 2023
No reasonable jury could have concluded that the carved-out labeling for petitioner’s generic carvedilol from 2007-2011 was itself evidence of intent to induce infringement.” Plainly, the Government brief states “The decision below is incorrect. GSK filed a supplemental brief in response to the Government’s brief.
Expert insights. Personalized for you.
Let's personalize your content