Regulatory

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.
The Center for Biosimilars® recaps the top stories for the week of October 14, 2019.
The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines." 
Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals. 
The bill prohibits these agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company. The bill would make violating these provisions punishable by civil penalty.
The Center for Biosimilars® recaps the top stories for the week of October 7, 2019.
Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.
The FDA has issued a complete response letter for Tanvex BioPharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen.
The state’s Department of Health and Human Services this week sent letters to firms that did not provide required information about production costs, marketing and advertising costs, patient assistance programs, wholesale acquisition costs, and historical increases, among other information.
The FDA has approved Pfenex’s follow-on teriparatide, PF708, referencing Forteo, for the treatment of osteoporosis in patients at high risk for fractures.
 

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