Pfenex Inc. (NYSE American: PFNX) and Alvogen today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted by our partner Alvogen for PF708 (teriparatide).
The Biosimilars Forum recently released new scoring analysis, which it commissioned from Avalere Health, on three policy proposals to increase use of and patient access to biosimilars.
Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue) on 23 May 2019.
Sandoz Canada welcomes British Columbia (BC) PharmaCare’s announcement to implement the Biosimilars Initiative with the goal to expand the use of biosimilars available on the market and generate significant cost savings to the healthcare system.
British Columbia is improving the sustainability of its PharmaCare program by expanding the use of biosimilars, which will create opportunities for new drug listings and boost existing coverage for patients.
U.S. Senators Mike Enzi, R-Wyo., and Maggie Hassan, D-N.H., introduced bipartisan legislation recently that would enhance education of biosimilar drug products in an effort to increase competition and lower the cost of biologic medicines.
Celltrion announced the approval of Herzuma (project name: CT-P6, trastuzumab-pkrb), a mAb biosimilar for breast and gastric cancer, from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) on May 20, 2019.
Recently, the Senate Committee on Health, Education, Labor and Pensions (HELP) introduced a discussion draft that included guidelines to educate patients and providers about biosimilars.
Recombinant glycosylated proteins segment of biosimilars market is estimated to grow at around 28.7% over the estimation period. Increase in number of people suffering from chronic disorders such as cancer and blood disorders will result in growing demand for biosimilars. Also, recent launch of molecular antibody biosimilars in developed regions of North America and Europe will boost the growth of recombinant glycosylated proteins over the forthcoming years.
On May 22, Alteogen Inc. (CEO Soon Jae Park), a South Korean biotechnology company developing Eylea biosimilar (ALT-L9) to treat macular degeneration, announced that it gained Investigational New Drug (IND) approval for Phase 1 clinical trial from Ministry of Food and Drug Safety in Korea.
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