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Union accounts for more than 90 percent of the gl
obal cumulative experience with biosimilar medicines, according to Maréchal-Jamil. “In the EU, every country uses biosimilar medicines, however there remains variability among countries and also within countries, depending on the biologic molecule and the therapeutic area.” Swedish company Xbrane expects to launch its first biosimilar in 2022. Payers and customers in the Nordic countries have been especially accepting of biosimilars, according to Pfizer Sweden Country Manager Malin Parkler. Pfizer’s current portfolio includes four approved biosimilars in the U.S. and EU for the treatment of cancer or supportive care, and approved biosimilars for the treatment of inflammatory conditions. In terms of guidance during production, “We work with a range of stakeholders including researchers, physicians, patients and policymakers to inform our development pipeline and bring these important therapies to the market,” Parkler informs. In September 2017, Pfizer filed a suit in U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson, arguing that Johnson & Johnson is preventing U.S. patients from using a biosimilar produced by Pfizer. No trial date has been set. “We filed this lawsuit to challenge practices that block access, choice and price competition for patients, so that U.S. patients have access to a wide range of treatment options at a competitive price,” says Andy Widger, Senior Director, Global Media Relations, for Pfizer. The lawsuit alleges that Johnson & Johnson’s anti-competitive practices 110 NORDICLIFESCIENCE.ORG concerning Remicade® (infliximab) have denied U.S. patients and the broader healthcare system the benefits of price competition and therapeutic options in the biologics marketplace in violation of federal antitrust laws, according to Widger. The suit maintains that Johnson & Johnson said it would withhold significant rebates to insurers for both current and future patients unless the insurers agreed to block coverage for Inflectra and other infliximab biosimilars, Widger noted. Despite the cost and numerous patent and legal issues, interest in biosimilars remains high. Currently the European Other barriers to biosimilar use are fears that they will not be as effective as the original drugs and there are insufficient inducements to develop and prescribe them, according to experts. “The lack of incentives and benefitsharing schemes, which require specific national policy interventions and measures [are issues],” says MaréchalJamil. Among the potential solutions she cites making sure the framework is patient-centric and the market mechanisms are supportive of healthy competition; the pricing, reimbursement and tendering processes and timelines enable timely biosimilar medicine launches, and the treatment guidelines are revised to include improved cost-efficiency where biosimilar medicines are available. “A competitive and sustainable European marketplace that supports both originator biologics and oncology biosimilars is necessary to obtain the