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December 13, 2018
Article
Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).
December 12, 2018
Article
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.
December 11, 2018
Article
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.
December 11, 2018
Article
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.
December 10, 2018
Article
Samsung Bioepis has announced that a 1-year follow-up study comparing event-free survival in patients treated with SB3, a biosimilar trastuzumab (approved in Europe as Ontruzant) showed that the biosimilar has similar safety and efficacy profiles to the reference Herceptin.
December 07, 2018
Article
A slowdown in overall spending was driven, in part, by reduced growth in spending on prescription drugs. In 2014, spending on these drugs grew by 12.4%; this pace saw just 0.4% growth in 2017.
December 06, 2018
Article
After increased pressure on pharmacy benefit managers to remake their approaches to rebates, CVS Health has announced that it will offer a new prescription benefit option in 2019 that will pass all drug makers' rebates back to its plan clients.
December 05, 2018
Article
The launch of biosimilar rituximab is an eagerly awaited event among US healthcare stakeholders who are cognizant of the high cost of intravenously (IV) administered rituximab in treating non-Hodgkin lymphoma (NHL). At the same time, another innovation in rituximab delivery—a subcutaneously administered rituximab formulation—has the potential to save both cost and time.
December 04, 2018
Article
For health systems like the Veterans Health Administration (VHA), where controlling costs while providing high-quality care is of heightened concern, achieving the best value for money in the prophylaxis of neutropenia can help to control the cost of cancer care.
December 04, 2018
Article
Celltrion’s CT-P10, a biosimilar rituximab that was FDA approved under the brand name Truxima in November 2018, is already in wide use for a host of indications in many regulatory territories. During this week’s 60th Annual Meeting and Exposition of the American Society of Hematology in San Diego, California, multiple research teams are reporting data that underscore the safety and efficacy of CT-P10 in hematological conditions.