Kelly Davio


Biosimilar, Reference Epoetin Alfa Have Similar Safety, Efficacy When Administered Subcutaneously

September 19, 2019

The FDA requested that Retacrit's maker provide data on subcutaneous administration, given that immunogenicity of a protein can be impacted by route of administration. Results from that study, newly published in Kidney International Reports, show that the subcutaneous administration of the biosimilar has similar safety and efficacy to subcutaneous administration of the reference (Epogen, Procrit).

Vial Sharing for Bevacizumab in Treating Eye Disorders Reduces Costs, Increases Access

September 18, 2019

Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.

As Biosimilars Close in for Its Blockbusters, Roche Looks to New Agents to Shore Up Sales

September 18, 2019

The drug maker indicates that, conservatively, it plans to see 60% to 70% erosion for rituximab (Rituxan, MabThera), trastuzumab (Herceptin), and bevacizumab (Avastin) by 2023, leaving a gap of approximately $9.6 billion for the company to fill.

A Decade of Biosimilar Filgrastim Experience Highlights the Scientific Basis for Extrapolation, Study Says

September 17, 2019

Sandoz’s biosimilar filgrastim was first approved in Europe in 2009 under the name Zarzio (later, the same drug was approved as Zarxio in the United States). Since that time, the number of biosimilars approved for use in the oncology field has grown substantially, and a recent review says that the past decade of experience with biosimilar filgrastim underscores the strong scientific basis for the extrapolation of indications for biosimilars.

Postmarket Barriers to Biosimilars Cost $2.2 Billion Since 2015, Says Biosimilars Council

September 17, 2019

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a second component of its recent white paper on barriers to biosimilars in the United States; the newly published segment highlights postmarket barriers to biosimilar adoption and says that they have taken a significant toll on the US healthcare system in terms of lost savings.

In Antitrust Case Over Remicade, J&J Wins the Right to Arbitration

September 16, 2019

The United States Court of Appeals for the Third Circuit has sided with Johnson & Johnson (J&J) and its Janssen division, requiring a dispute between the Remicade maker and Rochester Drug Cooperative to be sent to arbitration.

Patients With Rheumatic Diseases Face Substantial Hurdles in Accessing Treatment, ACR Says

September 16, 2019

While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.

Samsung Bioepis Launches Biosimilar Etanercept in Brazil

September 13, 2019

Samsung Bioepis has launched its biosimilar etanercept, SB4, in Brazil. The biosimilar, which is being sold as Brenzys, was approved in Brazil in 2017 to treat rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and nonradiographic axial spondyloarthritis.

New Data From PREVENT Show Benefits of Eculizumab in NMOSD

September 13, 2019

During this week’s meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers are presenting new data for eculizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder that typically affects the optic nerves and spinal cord and that can cause significant, irreversible disability.

With a Biosimilar on the Horizon, New Data Give an Important Look at Natalizumab in MS

September 11, 2019

Just last week, Sandoz indicated that it will commercialize a biosimilar of the multiple sclerosis (MS) drug natalizumab (Tysabri). This week, during the 35th meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers will present data that help contextualize natalizumab’s place in the treatment paradigm for MS.