News

Hungary-based Gedeon Richter announced today that it has launched a biosimilar teriparatide, Terrosa, in Europe. The drug, referencing Eli Lilly’s Forsteo (sold as Forteo in the United States), is used to treat osteoporosis. The product will also be sold under the brand name Movimya by the company's partner, Stada.

While drug makers who sell insulin in the United States have had the past decade to prepare for the transition, stakeholders within the diabetes community must grapple with the potential impacts that this regulatory change could have.

In a one-page order filed last week, a panel of judges for the US Court of Appeals for the Federal Circuit denied Genentech’s motion for an injunction that would have blocked Amgen from selling its biosimilar bevacizumab, Mvasi, pending the outcome of an appeal.

Researchers examining the mandatory switch of patients with rheumatoid arthritis (RA) from the originator etanercept (Enbrel) to the biosimilar etanercept (Benepali) found no changes in overall healthcare utilization or cost of healthcare following the switch.

Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.

Representative Elijah Cummings, D-Maryland, and Senator Bernie Sanders, I-Vermont, have sent letters to executives of 3 generic drug makers in which they ask for drug pricing information as part of a probe into the rising cost of generics.

With rising concern over rising drug prices, policymakers have sought a better understanding of the roles of pharmacy benefit managers (PBMs) in the drug supply chain and plans' and PBMs' efforts to manage Part D drug spending and use.

Samsung Bioepis has begun recruiting patients with paroxysmal nocturnal hemoglobinuria (PNH) in India for a phase 3 clinical study of its proposed eculizumab biosimilar, SB12, referencing Soliris.

The Center for Biosimilars® recaps the top stories for the week of August 12, 2019.

A recent study of a rapid point-of-care (POC) test shows that it is virtually identical at detecting antidrug antibodies (ADAs) to a biosimilar infliximab, SB2 (Renflexis, Flixabi), as a standard enzyme-linked immunosorbent assay (ELISA) and is suitable for therapeutic drug monitoring of any infliximab product.

LG Chem’s biosimilar etanercept, LBEC0101, referencing Enbrel, recently gained approval in Japan and the Republic of Korea. Among the data that led to its authorization were those deriving from a phase 3 study that demonstrated the biosimilar had equivalent efficacy and a comparable safety profile to the reference product. Recently, researchers reported on a single-arm, open-label extension study in patients with rheumatoid arthritis (RA) who completed the 52-week phase 3 study.

In its August 2019 network bulletin, UnitedHealthcare indicated that, beginning October 1, 2019, biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti), both made by Amgen, will be preferred products for commercial and community plans.

Negotiations between Congress and the Trump administration over ratification and implementation of the United States–Mexico–Canada Agreement (USMCA) have picked up speed in recent weeks. The USMCA was signed on November 30, 2018, ostensibly as a replacement for the original North American Free Trade Agreement (NAFTA).

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

Regeneron’s aflibercept (Eylea) has been approved by the FDA for a prefilled syringe (PFS) presentation. The 2-mg, single-dose, PFS will offer the greater ease of use less preparation than the vial presentation of the drug used to treat a range of eye disorders.

This week, a pair of papers detailing the clinical program for the biosimilar appeared in Pharmacology Research and Perspectives.

Concerns about overseas inspections continue in the wake of an HHS plan to create 2 potential pathways to allow the importation of some drugs that were intended for foreign markets.

This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.

Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.

Winnie Tiedemann, 73, of New Jersey lives with her son and his 5 children. Tiedemann was diagnosed with diabetes at age 25 and has been insulin-dependent for the past 20 or so years. Her out of pocket costs for insulin? Around $3600 a year.

The study was conducted in patients with moderately to severely active rheumatoid arthritis who previously completed the VOLTAIRE-RA study.

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

There remain many uncertainties and questions around the success of these agents. It is therefore critical for sponsors and other stakeholders to consider some of the potential hurdles and policy shifts facing anticancer biosimilar uptake and ultimately reimbursement in the United States.

The Center for Biosimilars® recaps the top stories for the week of August 5, 2019.

The August issue of JAMA Oncology features a Viewpoint that puts forth a free-market solution to lower high drug costs by changing dosing regimens without hurting efficacy using the approach of interventional pharmacoeconomics (IVPE).

OneOncology, a national partnership of community oncology practices, says that its partner practices have begun treating patients with 2 anticancer biosimilars: Kanjinti, a trastuzumab biosimilar referencing Herceptin, and Mvasi, a bevacizumab biosimilar referencing Avastin.