News

While the United States is still awaiting the launch of the first FDA-approved biosimilar epoetin alfa, erythropoiesis-stimulating agents were among the first biosimilars to become available in Europe. This month, Italian researchers published a post-authorization observational study that compared the efficacy and safety of 2 European biosimilars and the reference epoetin alfa in patients undergoing dialysis at 26 hospitals in 4 regions in Italy, and they concluded that their results support the comparable safety profiles of the originator and biosimilar products.

Studies have demonstrated that using follow-on and biosimilar granulocyte colony-stimulating factor (G-CSF) agents can produce cost savings and expand patient access to prophylaxis of febrile neutropenia. Now, a newly published budget impact analysis finds that even greater savings may be possible if patients self-administer these agents at home rather than visiting a provider to receive an injection.

This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.

Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.

The district court for the Eastern District of Pennsylvania has denied Johnson & Johnson’s motion to dismiss an antitrust civil action brought by Pfizer over infliximab.

This week, Samsung, the parent company of Samsung BioLogics and biosimilar development company Samsung Bioepis, announced plans to invest $22 billion across business lines, including biopharmaceuticals.

Celltrion has announced that it is ready to begin a phase 3 trial of its proposed bevacizumab biosimilar, CT-P16. The multicenter study will begin in Portugal and will eventually include approximately 150 sites in 20 nations in Europe, Asia, and South America.

The Center for Biosimilars® recaps the top 5 articles for the week of August 6, 2018.

CMS this week announced a policy that will allow Medicare Advantage (MA) plans to negotiate drug prices for physician-administered and other Part B drugs by allowing plans to employ the utilization management strategy known as step therapy to newly diagnosed patients.

Celltrion’s Korean plant has received its second Form 483 from the FDA in less than a year, only months after having received a warning letter for the same facility.

Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.

Express Scripts framed its formulary as a response to pharma: “Despite promises to limit price increases, drug makers are trying to game the market by delaying generic competition, blocking access to safe and effective biosimilars, and coyly deferring—not cancelling—list price increases,” it said.

The government has launched a consultation that outlines the proposed changes to its price controls, which require brand-name drug makers to pay the government 7.8% of their sales of products to the National Health Service.

Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.

The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.

During the 2018 annual conference of the United Kingdom and Ireland’s Prescribing and Research in Medicines Management, investigators reported on 2 questionnaire-based studies that highlighted the critical importance of provider education in the prescribing of biologics and biosimilars.

The Initiative for Medicines, Access, and Knowledge (I-MAK), a public interest team of attorneys and scientists who seek to ensure that patents do not obstruct patient access to affordable medicines, has issued a new report that details the number of patents drug makers have attempted to secure for the highest-grossing drugs in the United States.

Stada, a biopharmaceutical company based in Germany, recently announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.

Australia’s Therapeutic Goods Administration has approved Celltrion’s Herzuma—the country’s first biosimilar trastuzumab—referencing Herceptin.

Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.

The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

The Center for Biosimilars® recaps the top 5 articles for the week of July 30, 2018.

The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.

This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures, and as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption.

Vizient, a healthcare performance improvement company, recently released its Drug Price Forecast Highlights biannual report that provides an estimate of the change in the cost of medicines for 2019.

This week, the district court of Massachusetts granted Celltrion’s motion for a summary judgment of non-infringement of the last patent in question in the long-running Janssen v Celltrion case.

NHS Improvement, the body that oversees the financial stability, quality, and operational performance of England’s National Health Service (NHS) trusts, reports that switching patients to biosimilars and generics of high-cost drugs led to £324 million ($424 million) in savings in the last financial year, and that it could benefit from an additional £100 million ($131 million) in savings this financial year from greater biosimilar use.

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

The World Health Organization (WHO) has produced a draft Question and Answer (Q&A) document that gives additional clarification to its 2009 guidelines for evaluating similar biotherapeutic products, particularly with respect to evaluating biosimilars of monoclonal antibodies.