Kelly Davio

May 02, 2018

Though the European Medicines Agency (EMA) has instituted guidelines for the development of biosimilars, approval of these drugs is possible even in cases in which the guidelines are not followed, and even in which primary endpoints in studies are not met.

May 01, 2018

Filgrastim, used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy, is the first drug in the United States to have a biosimilar approved. While the biosimilar filgrastim was approved in 2015, few studies have compared the real-world incidence of FN, healthcare resource utilization, and costs among US patients using the reference product (Neupogen) and those using the approved biosimilar (Zarxio).

April 30, 2018

April was a notable month for regulatory action on biosimilars in the United States, and for regulatory developments in Europe.

April 30, 2018

At the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting, held April 23 to 26, in Boston, Massachusetts, several research teams presented posters relevant to the US adoption of biosimilars.

April 26, 2018

Retinal vein occlusion (RVO) is a prevalent, vision-threatening disease, of which macular edema is a common complication. Standard treatment for RVO-associated macular edema involves intravitreal treatment with anti–vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab, bevacizumab, or aflibercept. Despite success with these agents in clinical trials, anti-VEGF agents may be administered less frequently in clinical practice than in studies.

April 26, 2018

Jeffrey Capello, executive vice president and chief financial officer, divulged that Biogen intends to exercise its option to increase its stake in the Samsung Bioepis joint venture. Currently, Samsung BioLogics holds 94.6% of the company, and Biogen owns the remaining 5.4%.

April 25, 2018

While all eyes were on the Supreme Court of the United States’ ruling in the much-anticipated Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, the Court issued a second key ruling this week in SAS Institute v Iancu, Director, United States Patent and Trademark Office, et al—one that will also impact inter partes review (IPR) of biologic drug patents.

April 25, 2018

The European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), an umbrella organization that represents 34 patient associations around the world, recently released a report on healthcare inequities among nations and regions. In the report, the EFCCA identified disparities in access to biologics and biosimilars.

April 24, 2018

Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.

April 24, 2018

The Supreme Court of the United States (SCOTUS) ruled today in the case of Oil States Energy Services, LLC, v Greene’s Energy Group, LLC, that the inter partes review process for reviewing patents does not violate the Constitution by adjudicating public rights outside of an Article III court. The Court ruled 7 to 2, with Chief Justice John Roberts and Justice Neil Gorsuch dissenting.