Business

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.

German drug maker Formycon released its third quarter financial results on Monday, and reported that it plans to launch its biosimilar ranibizumab candidate, FYB201, in the United States in 2020.

Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.

Janssen-Cilag International’s biologic drug guselkumab (Tremfya) has received approval from the European Commission (EC) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.

Drug maker Biocon has launched a biosimilar bevacizumab (referenced on Avastin) in India.

Our latest infographic covers 4 key takeaways from the SMi Biosimilars North America 2017 conference.

A new study, the phase 3 IMpower150, demonstrated Genentech’s atezolizumab (Tecentriq) and innovator bevacizumab (Avastin) plus paclitaxel and carboplatin chemotherapy significantly reduced the risk of disease worsening or death in the treatment of advanced lung cancer.

Health Canada looks to lower the maximum price for drugs, but doing so could delay patient access, warns Montreal Economic Institute.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of November 20.

This past week, the FDA began the long-awaited process of adding a 4-letter suffix devoid of meaning, to the end of newly approved biologics’ nonproprietary names.

Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,

Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published study in Global Health suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.

Swiss drug maker Roche has filed a lawsuit against Pfizer in a Wilmington, Delaware federal court, seeking to block the rival developer from launching a biosimilar trastuzumab in the United States.

A recently unsealed lawsuit alleges that drug maker Eli Lilly illegally worked with Healthstar Communications and VMS Biomarketing to provide free nursing services to induce healthcare providers to prescribe the drug maker’s insulin products Humalog and Humulin.

Samsung Bioepis announced today that it has received the European Commission's (EC) marketing authorization for its biosimilar trastuzumab, SB3, for the treatment of early breast cancer, metastatic breast cancer, and metastatic gastric cancer. SB3 is the first biosimilar trastuzumab, referenced on Roche’s blockbuster Herceptin, to receive European regulatory approval.

In an effort to better address the needs of patients taking reference etanercept (Enbrel), Amgen has launched an ergonomically designed cartridge with a reusable auto-injector in the United States as an additional administration option.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of November 13.

A new CMS proposed rule seeks to encourage the use of lower-cost biosimilars instead of reference biologics under Medicare Part D. The proposed rule would modify the definition of generic drugs—for the purposes of non–low-income-subsidy (LIS) catastrophic and LIS cost-sharing—to include biosimilar therapies.

In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.

Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.

Theradiag, a French company that specializes in in vitro diagnostics and theranostics, has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits to monitor patients treated with Biogen’s infliximab biosimilar Flixabi, which was approved in Europe in 2016.

The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims—with prejudice—against a biosimilar developer.

Interest in needle-free drug delivery has increased as biologics manufacturers look for ways to give their originator drugs a competitive advantage over oncoming biosimilar competition.

Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission to treat multiple rheumatic diseases after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2017.

Samsung Bioepis announced this week that it has gained regulatory approval in the Republic of Korea for its trastuzumab biosimilar, SB3.

Drug makers Amgen and Allergan announced on Friday that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ABP 215, the companies’ bevacizumab biosimilar. CHMP recommended the biosimilar for approval for the treatment of multiple cancer indications.

“If the patient doesn’t have better access, you don’t need a biosimilar," argues Roy Fleischmann, MD.