Regulatory

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

This week, Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label variation for its reference pegfilgrastim to now include the branded Neulasta Onpro Kit.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

The FDA and the European Medicines Agency announced today that the mutual recognition agreement on good manufacturing practice (GMP) inspections between the European Union and the United States now includes 4 additional EU member states.

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

Drug maker Biocon has received a Form 483 from the FDA after an inspection of its manufacturing facility in Malaysia.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 19, 2018.

The international initiative AllTrials has launched a new online tracking tool that publicly discloses which research entities have not reported data from clinical trials.

An editorial recently published in The BMJ discusses addresses 1 of the most commonly misunderstood biosimilar concepts: extrapolation.

The Patients for Biologics Safety and Access (PBSA) is calling on the FDA to revise its prescriber-directed online educational materials on biosimilars. However, not all patient groups agree with PBSA’s stance.

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

A white paper released this month by the Association for Accessible Medicines (AAM) says that brand-name drugs are behind high prescription drug costs, and that those costs aren’t only hurting patients’ financial wellbeing, but also endangering their health.

Scott Gottlieb, MD, Commissioner of the FDA, is calling for changes to biosimilar regulation to help facilitate biosimilar approval, market entry, and competition.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 12, 2018.

Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”

“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 5, 2018.

On January 29, the European Medicines Agency (EMA) held a joint press conference with members of the Dutch government to unveil plans for the new customized headquarters facility being built in the Zuidas business district.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 29, 2018.

Before the Wisconsin State Assembly’s health committee today is Assembly Bill 679, an act to address biosimilar substitution at the pharmacy level.

Biosimilars have reached a tipping point in the US market, according to a new drug pricing forecast from consulting company Vizient.

The FDA has issued a warning letter to Celltrion, maker of the infliximab biosimilar Inflectra. The company announced today that, on January 30, the company received a letter from the agency that “raises issues related to certain manufacturing process[es]” at its Incheon, Republic of Korea facility.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains some of the challenges with proposals to allow the United States to import cheaper drugs from Canada or other highly regulated pharmaceutical markets.

The Therapeutic Goods Administration has announced that it will not use 4-letter suffixes in naming biologic and biosimilar medicines (as the FDA currently requires).

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.

This week, the FDA announced that it has issued a direct final rule that amends the biologics regulations to remove what it calls “outdated requirements” and help to eliminate inconsistencies and duplicative processes.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 22, 2018.