Regulatory

Senators Amy Klobuchar (D-Minnesota) and Chuck Grassley (R-Iowa) recently reintroduced bipartisan legislation aimed at bringing down prescription drug costs.

The House Committee on Oversight and Reform has launched a wide-ranging investigation into prescription drug pricing in the United States.

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.

Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.

The Center for Biosimilars® recaps the top news for the week of January 7, 2019.

During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.

This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.

The Center for Biosimilars® recaps the top news for the week of December 31, 2018.

2018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.

The Center for Biosimilars® recaps the top news of 2018.

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.