On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA. The trial is a 52-week trial in 348 patients...more
On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
On October 12, 2022, Amgen released its 2022 Biosimilar Trends Report. Since we posted on Amgen’s report preview in July, the total number of biosimilars that have been approved in the United States has increased from...more
Under Section 11403 of The Inflation Reduction Act, effective starting on Monday, October 3, 2022, and for the next five years, Medicare Part B will pay healthcare providers an 8% add-on fee for qualifying biosimilars,...more
10/13/2022
/ Biosimilars ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Inflation Reduction Act (IRA) ,
Interchangeability ,
Medicare ,
Medicare Part B ,
Pending Legislation ,
Prescription Drugs
On August 1, 2022, Fresenius Kabi announced that the FDA accepted for review its Biologics License Application (BLA) for MSB11456, a biosimilar candidate for ACTEMRA (tocilizumab). The BLA includes both subcutaneous...more
Formycon recently announced its sales and earnings figures for the first quarter of 2022. Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to EUR -4.0 million (Q1/previous year: EUR -1.7...more
On May 19, 2022, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) issued opinions recommending the refusal of marketing authorization for Prestige BioPharma Ltd.’s HD201, TUZNUE and...more
On April 13, 2022, Amneal Pharmaceuticals, Inc. announced that the FDA approved its BLA for bevacizumab-maly, a biosimilar of Roche’s AVASTIN. The product will be marketed under the proprietary name ALYMSYS and represents...more
On March 14, 2022, Prestige BioPharma Ltd., a Singapore-based biopharmaceutical company, announced positive safety and efficacy results in a Phase III study (“TROIKA”) for HD201, a biosimilar to HERCEPTIN (trastuzumab). The...more
On January 28, 2022, the Food and Drug Administration (FDA) approved Genentech’s VABYSMO (faricimab-svoa) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). According to the...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year...
President Biden Signs Orange Book Transparency Act -
In January, we reported that President Biden...more
12/31/2021
/ Biden Administration ,
Biosimilars ,
BPCIA ,
Drug Pricing ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Guidance Update ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Orange Book ,
Patent Applications ,
Patent Examinations ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review ,
Prescription Drugs ,
Purple Book ,
Statutory Requirements ,
Transparency ,
USPTO
On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were...more
12/6/2021
/ Biologics ,
Biosimilars ,
EU ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Information Reports ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs