The Center for Biosimilars Staff

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.

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

At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).

Two recent studies have provided long-term data on the safety and efficacy of switching patients from Remicade to its biosimilars.

Drug maker Celltrion has entered into a contract manufacturing organization agreement with Baxter BioPharma Solutions for the production of its biosimilars in the United States.

The United Food and Commercial Workers Local 1500 Welfare Fund has filed an antitrust lawsuit against Johnson and Johnson in Pennsylvania’s Eastern District Court. The suit takes aim at the drug maker over its blockbuster innovator infliximab, Remicade.

The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducing manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.

A recent study found that injectable anticancer drugs steadily increase in price, even after competition enters the market.

This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

In its third-quarter earnings report, Swiss drug maker Novartis announced that its net sales have risen by 2%, and net income by 10%, compared to the same period last year. The company credited its biosimilars business as a key factor in its growth.

The Australian Medical Association has issued a comment to the nation’s government concerning new proposals aimed at increasing biosimilar uptake in Australia.

Data from 5 studies presented at the European Society for Medical Oncology (ESMO) 2017 meeting highlighted the progress of biosimilar trastuzumab candidates.

In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

Nichi-Iko has disclosed that it is currently engaged in consultations with the FDA concerning the demonstration of interchangeability of its proposed biosimilar with the reference Remicade.

On Monday, a Federal Circuit judge invalidated Allergan’s patents for its dry-eye drug, Restasis, on the basis of obviousness. He also ordered the joinder of the Saint Regis Mohawk Tribe with Allergan as a co-plaintiff in the action against drug maker Teva, which seeks to develop a follow-on version of the drug.

The Senate’s Health, Education, Labor and Pensions (HELP) Committee today heard testimony from pharmaceutical manufacturers and the supply chain in a full committee hearing titled “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.”

In an ongoing litigation over biosimilar adalimumab, AbbVie, maker of the blockbuster reference adalimumab (Humira), denied biosimilar developer Boehringer Ingelheim’s claims that the company has been padding its patent estate with overlapping patents in an effort to protect its drug from competition.

Who will be the first manufacturer to succeed in gaining European or United States regulatory approval for a biosimilar pegfilgrastim product?

On this World Arthritis Day, patients with inflammatory diseases have increasing treatment options as biosimilars gain regulatory approval and become more widely available for use. New clinical data also help support the efficacy and safety of these therapies.

Navigator programs, which provide outreach, education, and enrollment assistance to consumers eligible for health coverage through the Affordable Care Act marketplace and Medicaid, learned on August 31, 2017, about a 40% CMS spending cut on the program, with a wide disparity in funding cuts per state.

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.

An international panel of healthcare stakeholders recently released consensus recommendations for the use of biosimilars to treat rheumatologic diseases. Learn more about what the panel had to say.

After having warned that it could lose up to 94% of its staff in a relocation from its current home in London, United Kingdom, The European Medicines Agency (EMA) this week revealed its top location choices for the agency’s upcoming move.

The Federal Trade Commission (FTC) has announced a November 8 workshop that will focus on competition issues related to prescription drug marketing.

In addition to addressing the humanitarian toll that Hurricane Maria has taken on the residents of Puerto Rico, an additional, long-term challenge in coping with the storm’s aftermath is the potential for drug shortages.