Regulatory

Medicines for Europe says that the sustainability of healthcare budgets in European nations has been “intensely pressured” in recent years by factors including an aging population and the introduction of high-cost drugs, and that governments aiming to address those challenges have resorted to austerity measures that have “driven the prices of some off-patent medicines to unsustainably low levels."

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 25, 2017.

Drug maker Amgen announced today that it has reached a global settlement with AbbVie, developer of reference adalimumab (Humira), over Amgen’s biosimilar adalimumab, Amgevita.

The European Medicines Agency released results of an internal survey that asked staff to which proposed cities they would consider relocating. The lowest-ranking city was one to which only 6% of respondents were likely or very likely to relocate.

Republican efforts to repeal and replace the Affordable Care Act may have stalled once again with the failure of the Graham-Cassidy bill on Thursday, but advocacy groups intend to keep healthcare—and the high cost of prescription drugs—at the forefront of Congress’ agenda.

Amgen has filed a news Biologics Price Competition and Innovation Act (BPCIA) suit against rival drug maker Mylan.

Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.

The FDA has issued a complete response letter (CRL) for Johnson and Johnson’s proposed rheumatoid arthritis (RA) drug, sirukumab. Janssen Biotech, a division of Johnson and Johnson, had filed a Biologics License Application (BLA) for the interleukin-6 (IL-6) inhibitor, including data from a global phase 3 clinical development program, in September 2016.

Scott Gottlieb, MD, Commissioner of the FDA, has signaled that while biosimilars are on the rise, they need a boost from stakeholders if development of these therapies will continue to grow.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.

Last week, CMS closed its comment period on the 2018 Revisions to Payment Policies under the Physician Fee Schedule. Multiple stakeholder groups within the biosimilars industry submitted comments to CMS with respect to its policy on biosimilar reimbursement.

In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases.

Last week, Irish drug maker Allergan announced that it had transferred its patents for its cyclosporine ophthalmic emulsion, Restasis, to the Saint Regis Mohawk Tribe. Allergan said in a statement that the Tribe now owns all Orange Book-listed patents for the dry eye treatment, and that the Tribe is filing for a motion to dismiss an ongoing inter partes review on the basis of sovereign immunity.

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions on 2 biosimilar candidates.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 11.

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

During a panel on the second day of the 2017 AAM Biosimilars Council Conference, held in Washington DC, regulatory leaders from Pfizer and Sandoz shared their experiences with the development of their biosimilar products: epoetin alfa (Epogen) and etanercept (Erelzi), respectively.

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

At the 2017 AAM Biosimilars Council Conference, policy experts addressed the question of how biosimilar developers can navigate the complex and challenging biologics marketplace in the United States.

Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.

How can the US healthcare system learn from the European Union on market penetration for biosimilar products?

The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

This week, the FDA released a Form 483 noting observations made when inspecting Celltrion’s manufacturing facility in May and June 2017. The heavily redacted form notes 12 observations.

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.