News

CMS is proposing a change to lower cost-sharing and improve enrollee incentives to choose biosimilars over reference biologics, and to reduce costs to both Medicare Part D enrollees and the Part D program. This objective would be accomplished by revising the definition of generic drug (§ 423.4) to include follow-on biologic products approved under the section 351(k) biosimilar pathway.

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

A new review discusses the systemic treatment of psoriasis and recommends biologics and biosimilars for long-term treatment of psoriasis because of their better tolerability and safety compared with other systemic treatments, which are limited largely by poor tolerability and cumulative toxicity.

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.

The United Kingdom's National Institute for Health Research (NIHR), part of the National Health Service (NHS), has created a website to educate the public about biosimilar drugs.

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,

A retrospective Chinese study of 59 people with brain edema related to metastatic cancer finds that bevacizumab (Avastin) is an effective and relatively safe treatment for brain edema, with a low risk for cerebral hemorrhage.

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.

A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.

The American College of Rheumatology (ACR) has voiced its approval of CMS’ attempts to lower the cost of drugs under Medicare Part D, but also called on the organization to allow more rheumatologists, including those in small practices, to take part in alternative payment models (APMs).

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.

Amsterdam, Netherlands, has won its bid to become the new home of the European Medicines Agency.

A recent Health Technology Assessment (HTA) report by the United Kingdom’s National Institute for Health and Care Excellence (NICE) concludes that adalimumab, etanercept, and ustekinumab improve the symptoms of psoriasis in children and young people in the short term, but the cost-effectiveness of these medications requires further study.

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.

Four recent studies investigated the proposed etanercept biosimilars SB4, LBEC0101, CHS-0214, and GP2015.

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.

We need a medical community that is fully educated about the benefits of biosimilars so that the promise of these drugs can be fully realized in the United States.

Australian researchers Kellie A. Mouchemore, PhD, and colleagues urge caution in the use of granulocyte colony stimulating factor (G-CSF) in neutrophil recovery following chemotherapy for breast cancer because there is increasing evidence that G-CSF can promote metastasis.

As part of the final CY2018 Medicare Physician Fee Schedule (PFS) policy, biosimilars will each have unique Healthcare Common Procedure Coding System (HCPCS) codes and payments under Medicare Part B, starting January 1, 2018.

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 ability to identify factors that predict efficacy of anti–tumor necrosis factor (TNF) agents is crucial if clinicians are to optimize treatment and minimize side effects and costs.

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.

The European Federation of Pharmaceutical Industries and Associations has released the results of a survey it conducted among its membership into how patient access to medicines could suffer after the United Kingdom exits the European Union.

The South Centre, an intragovernmental organization of developing nations headquartered in Geneva, Switzerland, has issued a new report on biosimilars that calls on regulatory bodies to institute an approval pathway for “biological generics” in favor of biosimilars.