Kelly Davio

August 21, 2019

Along with innovations in design comes the question of patients’ willingness to pay for features that differentiate self-injection devices from one another.

August 21, 2019

This week, researchers reported updated results from a post hoc subgroup analysis from the adjuvant period of treatment in the biosimilar’s phase 3 trial; these results, say the authors, demonstrate that the biosimilar, used in the adjuvant setting, has comparable efficacy and safety to the reference at 1 year.

August 20, 2019

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.

August 20, 2019

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.

August 19, 2019

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.

August 19, 2019

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.

August 16, 2019

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.

August 15, 2019

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.

August 15, 2019

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.

August 14, 2019

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