FDA Approves First Subcutaneous Infliximab Product - Center for …
WEBOct 23, 2023 — The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on Remicade (reference intravenous infliximab). The intravenous version of Zymfentra is marketed as Inflectra (also, infliximab-dyyb), Celltrion's ...
Kashiv, Amneal Receive First FDA Approval for Their Filgrastim …
WEBMar 3, 2022 — Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022. The FDA has approved Releuko (filgrastim-ayow), a filgrastim biosimilar referencing Neupogen developed by Amneal Pharmaceuticals and Kashiv Biosciences. The biosimilar marks the …
Center for Biosimilars®
WEBSarfaraz K. Niazi, PhD, explains the FDA's new guidelines on post-approval changes for biosimilars, emphasizing the processes for reporting modifications, comparability assessments, and the potential for biosimilars to introduce new indications or formulation changes, which could significantly impact their market competitiveness and accessibility.
FDA Approves Amgen's Trastuzumab Biosimilar, Kanjinti
WEBJun 13, 2019 — The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.. The news of the approval comes just a week after the 2019 American Society of Clinical Oncology Annual Meeting, where researchers reported new safety data from ...
Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin …
WEBMar 4, 2019 — Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price. The price of insulin has been top-of-mind for many lawmakers from both sides of the aisle, starting with a Senate ...
Despite Steep Discounts, Humira Biosimilars Are Priced More Than ...
WEBJul 17, 2023 — Throughout 2023, 9 FDA-approved adalimumab biosimilars are projected to enter the US market. As of the second week of July 2023, 8 had entered the market, beginning with Amgen’s Amjevita (adalimumab-atto) in January. Amjevita launched with a dual price strategy, where 2 versions of the drug would launch at 2 different prices (5% and 55% lower than the current price of Humira) to both entice ...
Real-world Study of Reference vs Biosimilar Ranibizumab for …
WEBApr 7, 2022 — A retrospective, real world study found similar effectiveness and safety of biosimilar ranibizumab (Razumab; Intas) and its reference product (Accentrix; Novartis) in patients with diabetic macular edema (DME) in a network of eye care centers and teaching hospitals in eastern India.
FDA Approves Semglee Insulin Glargine as First Interchangeable …
WEBJul 29, 2021 — The FDA has approved Biocon Biologic's Semglee insulin glargine as an interchangeable biosimilar, referencing Lantus. The approval carries with it many hopes for stronger competition in the insulin market, which is dominated by a handful of brands and characterized by stubbornly high prices. The approval of Semglee was much anticipated; it …
FDA Releases Final Guidance on Immunogenicity Testing for …
WEBFeb 8, 2019 — The FDA recently released final guidance about the use of therapeutic proteins in developing biologics and biosimilars. "Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection" represents current FDA thinking about developing and validating assays for anti-drug antibody (ADA ...
ACMA Begins Board Certification Program for Biologics, …
WEBDec 5, 2022 — In total, the program will cost registrants $1999. The application fee is $49 and the entire course costs $1000. The examination fee amounts to $800 and the credentialing fee costs $150. AMCA allows registrants to pay once for the whole course, to pay in 3 monthly installments of $716.33, or to pay through a …