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

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.

Pharmaceutical manufacturers often pay significant rebates on brand-name medications to pharmacy benefit managers or health plans to reduce the cost of pharmacy benefits and promote their brand-name drugs. Traditionally, these rebates have been provided to payers—not to health plan members.

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.

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.”

Last week, Amgen filed a new lawsuit against Genentech in a California district court. The suit seeks a judgment that Amgen’s newly FDA-approved bevacizumab biosimilar, bevacizumab-awwb (Mvasi) has not infringed and will not infringe on 27 patents for Genentech’s reference bevacizumab treatment, Avastin.

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

UK trade group The Association of British Pharmaceutical Industry announced last week that the Administrative Court has denied its application for judicial review of a new National Health Service drug pricing policy.

Amazon may be in the final phase of its decision to enter the online prescription drug sales market, according to analysts. Although Amazon has declined to comment, experts believe the company will decide before Thanksgiving whether it will enter the marketplace.

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.

A European study published this week finds that, at a minimum of 3.3 years after market entry, there was no conclusive evidence that many oncology drugs approved by the European Medicines Agency between 2009 and 2013 either extended or improved life in most oncology indications.

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

Indication-based pricing is a method used to reimburse drug makers according to a drug’s indication-specific value when the drug has multiple indications. A number of healthcare payers have already implemented or are planning to implement IBP, including Express Scripts, the largest US pharmacy benefit manager.

The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35% higher than it was in 2014, according to pharmacy benefit manager Express Scripts.

Drug maker Shire has filed suit in a federal court in Newark, New Jersey, alleging that rival Allergan has violated antitrust laws in trying to preserve market share of its cyclosporine ophthalmic emulsion (Restasis) by blocking competition from Shire’s dry-eye drug, lifitegrast (Xiidra), on the Medicare Part D formulary.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.

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."

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.

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

The California legislature has passed SB 17, a major effort to ensure transparency in drug pricing.

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.

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.

Healthcare company Fresenius Kabi has initiated a $250 million expansion of its Illinois manufacturing location and acquired Merck KGaA's biosimilars business.

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.

At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.

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.

Drug maker Pfizer announced today that it has filed a district court lawsuit in the Eastern District of Pennsylvania against Johnson and Johnson.

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