Regulatory

This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Mylan and Biocon have received final approval from the European Commission to market their trastuzumab biosimilar, Ogivri, referencing Herceptin.

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

The Center for Biosimilars® recaps the top news for the week of December 10, 2018.

On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.

Pfenex announced this week that it submitted to the FDA a New Drug Application (NDA) for its PF708, a teriparatide follow-on referencing Eli Lilly’s Forteo for the treatment of osteoporosis.

The Center for Biosimilars® recaps the top news for the week of December 3, 2018.

In the United States, Amgen has 57 patents on Enbrel, whereas in Europe it has 20, and in Japan it has 18.

Last month, the European Parliament’s Health Committee introduced amendments to Supplementary Protection Certificate (SPC) manufacturing waivers. On December 4, 2018, the committee voted in favor of the amendments.

In revised draft guidance published in October 2018, the FDA announced its intention to crack down on citizen petitions that seek to delay competition from generic or biosimilar drugs. Now, in a comment letter, the Federal Trade Commission (FTC) has said that it stands ready to work with the FDA on curtailing abusive petitions.

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

The Center for Biosimilars® recaps the top news for the week of November 26, 2018.

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

The Center for Biosimilars® recaps the top news for the week of November 19, 2018.

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.