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While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

The House Ways and Means Subcommittee on Trade heard testimony this week from labor leaders and others about a revised trade agreement that some say will hurt the biosimilar industry in the United States.

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.

Lupin and YL Biologics announced today that they have received approval to manufacture and sell YLB113, a biosimilar etanercept product, in Japan. The product will be Lupin’s first biosimilar to come to the Japanese market.

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.

The Center for Biosimilars® recaps the top news for the week of March 18, 2019.

Some stakeholders raised questions about how orphan drugs or biosimilars would be analyzed in the report. The Institute for Clinical and Economic Review's (ICER's) response to both were similar: it did not understand why drugs for orphan diseases or the market entry of biosimilars would lead to rapid price increases.

The European Commission has approved Roche’s innovator rituximab, sold in Europe as MabThera, for the treatment of pemphigus vulgaris (PV), a rare autoimmune disorder. The approval marks the first biologic approval for PV in the European Union, and the first major new therapeutic option in 60 years.

The Biosimilars Forum and Medicines for Europe today released a joint white paper that discusses how Europe has successfully sustained its multisource biosimilars market for the past 10 years. The forum also suggests that the United States make structural changes in order to achieve similar success.

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

Sagent Pharmaceuticals, a division of Nichi-Iko Pharmaceutical Co Ltd, announced earlier this month that it has purchased an FDA-approved manufacturing site in Raleigh, North Carolina, from Xellia Pharmaceuticals.

This week, Novartis announced that Richard Francis, chief executive officer (CEO) of the company’s Sandoz division, will step down on March 31.

According to the investigators, their data support the further development of CT-P16 as a bevacizumab biosimilar.

The Center for Biosimilars® recaps the top news for the week of March 11, 2019.

The United Kingdom’s Competition and Markets Authority has closed an investigation into an alleged anticompetitive discount scheme related to brand-name infliximab, Remicade.

The new acting chief of the FDA, Ned Sharpless, MD, has a track record with the biotechnology industry and a friendly relationship with the man he is replacing, Scott Gottlieb, MD.

Patients using expensive specialty medications, such as those that treat inflammatory diseases, are particularly impacted by pharmacy benefit manager (PBM) rebates, given the relationship of rebates to price. In the case of biosimilars, rebate strategies may lead to reference biologics being placed on preferred formularies in the United States while less expensive options are kept off the formulary.

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

The Center for Biosimilars® recaps the top news for the week of March 4, 2019.

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

The launch of biosimilar adalimumab products in the European Union in October 2018 was an important moment for health systems in serious need of cost savings on one of their top drugs for spending: Humira. Now, early data show that adalimumab biosimilars are off to a strong start in the EU market.

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

The FDA has approved a subcutaneously administered version of the brand-name trastuzumab, Herceptin. The new formulation, trastuzumab and hyaluronidase-oysk, is a combination of the anticancer agent trastuzumab and an endoglycosidase that allows for the administration of higher volumes and enhanced absorption, and it has been approved under the name Herceptin Hylecta.

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.