2014 Biosimilars Drug Development 
FDA Law Blog: Biosimilars
APRIL 8, 2025
OGDP is one of several offices in OGD, and it was composed of three divisions: the Division of Legal and Regulatory Support, the Division of Orange Book Publication and Regulatory Assessment, and the Division of Policy Development (DPD). Leading FDAs implementationof the Drug Competition Action Plan (DCAP).
Express Pharma
JULY 3, 2023
How is the industry’s approach to drug development transforming? How is Waters aiding advancements in drug development? A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. What are the imperatives that led to this change?
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Safe Biologics
NOVEMBER 12, 2023
6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.
European Pharmaceutical Review
JULY 4, 2024
4,6 Five patent issues that European biosimilar developers should consider before entering the US market Quality control of the botanical drug substances was one of the critical factors that led to barricades during the development of Veregen and Mytesi. BMB Reports. 2017;50(3):111–6. Premier Consulting [Internet].
FDA Law Blog: Biosimilars
JANUARY 7, 2024
To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.
PharmaShots
APRIL 10, 2023
Moreover, the ceaseless trials of pharmaceutical companies in the research of drugs for several disease conditions have transformed the course of therapeutics. The fine insulin powder is inhaled and goes to the lungs, which further infuses into the blood through tiny blood vessels. It works for T1DM and T2DM.
Big Molecule Watch
MARCH 12, 2025
With 10 years of litigation since the first BPCIA complaint on NEUPOGEN (filgrastim) was filed in 2014, trends are becoming apparent that should cause all biopharma companies to reassess how they protect biologics and plan for biosimilar launch.
Expert insights. Personalized for you.
96 
Let's personalize your content