Kelly Davio

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.

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 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.

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.

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.

During yesterday’s Federal Trade Commission public workshop on drug pricing competition, Scott Gottlieb, MD, Commissioner of the FDA, called on drug makers to “end the shenanigans” that delay drug competition in the US marketplace.

On Tuesday, 2 research groups presented findings from studies conducted in patients with rheumatoid arthritis (RA) who were switched from reference rituximab to a biosimilar therapy.

In a presentation titled “Biosimilar Medicine: Changing Landscape in Health Care,” given on Monday at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, J. Eugene Huffstutter MD, FACP, FACR, shared practical considerations for using biosimilars in the rheumatology clinic.

Two posters presented today at the American College of Rheumatology’s 2017 meeting in San Diego, California, highlight the gaps in US rheumatologists’ knowledge concerning biosimilar therapies, and underscore the importance of greater physician education about biosimilar medicines.

In the evolving world of biologic therapies, a class of follow-on biologics—so-called "biobetters"—is emerging as a new category of products.

Current regulations discourage the use of the more cost-effective bevacizumab and lead to unequal patient access to higher-cost ranibizumab and aflibercept.

In terms of both clinical data and sales, drug makers Celltrion and Pfizer have seen recent gains for their infliximab biosimilar, CT-P13 (Inflectra, Remsima).

New data show that switching patients with Crohn’s disease to CT-P13 from the reference infliximab led to comparable efficacy, safety, and tolerability between the 2 treatments over a 24-week period. The full 54-week results of the phase 3 study support the long-term effectiveness of treatment with CT-P13, the researchers say.

The biologic has the potential to deliver effective treatment for adult patients with generalized myasthenia gravis, but it comes at a high cost.

Sandoz announced today that its biosimilar pegfilgrastim has been accepted for review by the European Medicines Agency (EMA).

Russian biosimilar developer Biocad has won a legal battle that will allow it to move forward with its rituximab biosimilar.

Patients with rheumatoid arthritis (RA) have high healthcare utilization and high healthcare costs, which place a burden on health systems and patients alike. However, a recently published retrospective cohort study found that effective treatment for RA (namely, treatment with etanercept) may lead to lower overall and lower RA-related healthcare utilization.

The FDA has released a new set of educational materials concerning the nature and the prescribing of biosimilar therapies.

A paper by Matti Aapro, MD, recently published in Supportive Cancer Care, outlined, for the first time, consensus recommendations on using pegfilgrastim in particular patients and therapeutic scenarios.

New data from an extension period of a phase 3 study of Samsung Bioepis’ SB2 (Renflexis) in patients with moderate to severe rheumatoid arthritis found that there was no clinically meaningful difference in safety, efficacy, or immunogenicity in patients who were switched from reference infliximab to the biosimilar compared with patients who continued treatment with either the reference or the biosimilar without switching.

Rituximab, which is approved for the treatment of some cancers and inflammatory conditions, also holds significant promise for patients with neurological diseases.

Health insurer Anthem has announced that it will launch its own pharmacy benefit management (PBM) company, IngenioRx, that will operate in partnership with CVS Health, in 2020.

A study newly published in the Journal of Clinical Oncology found that, regardless of competition or additional approved indications, injectable anticancer drugs are subject to steady increases in price after launch.

A newly published study found that the prevalence of T helper (Th) lymphocytes, specifically Th9 cells, is higher in patients who have rheumatoid arthritis, and that these cells may also be involved in immune responses against reference infliximab.

Drug manufacturer JCR announced last month that it has submitted a marketing approval in Japan for JR-051, a proposed agalsidase beta biosimilar referenced on Fabrazyme.