Policy

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses current FDA guidance on the naming and labeling of biosimilar treatments.

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.

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.

Amanda Forys, MSPH, discusses the critical lack of clarity in the US biosimilars marketplace.

CMS has announced a change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar product.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 30.

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.

Revisions to the CMS billing code system could be announced November 1, 2017, potentially impacting how biosimilars will compete with reference products.

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.

The Center for Biosimilars® recaps the top 5 stories in biosimilars news for the week of October 23.

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

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.

A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.

Drug prices in several disease areas outpace other healthcare expenditures and result in inadequate availability of essential medicines globally, according to a recently published review.

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

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

The World Health Organization (WHO) has announced that, at present, it will not proceed with its proposal to use biological qualifiers (BQ) to assign international nonproprietary names to biosimilars.

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.

While no one argues that orphan drugs that treat rare diseases can be expensive, the drugs’ reputation for being budget-busters is not borne out by a data presented in a recent report by Quintiles IMS Institute.

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.

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.

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.”

Robert Cerwinski, JD, partner at Goodwin, explains why Hatch-Waxman litigation may provide a smoother path than does the Biologics Price Competition and Innovation Act.

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.

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.

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.

President Donald Trump today signed an executive order on healthcare. The order will allow businesses to form associations that will have the ability to purchase health coverage from across state lines.

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.

Judge William C. Bryson has ordered Allergan to file a brief for a federal patent infringement case by Friday, October 13, after questioning whether the drug maker’s recent transfer of drug patents to a sovereign tribe was a “sham.”