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Eli Lilly says that it will not comply with a 2017 California law on drug pricing, and now the state senator who sponsored the bill is hitting back against the drug manufacturer, calling the company’s activities to promote its diabetes programs “disingenuous and offensive.”

In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.

Clinical director of the Irish health technology assessment (HTA) body National Centre for Pharmacoeconomics (NCP), Michael Barry, MB, FRCPI, PhD, recently said in an interview with Irish media that the lack of uptake of biosimilars in Ireland is “an issue that should be tackled,” and he proposed approaches to do just that.

Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.

In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.

CVS Caremark will allow clients to exclude any drug launched at a price greater than $100,000 per quality-adjusted life year from their plans.

Now that multiple biosimilars of adalimumab (Humira) are approved, though none have launched in the United States or European Union, attention is turning toward the next wave of biosimilar candidates.

While US patients with diabetes await the launch of the follow-on, which is expected to offer a welcome cost-savings, newly published data from a 52-week clinical trial in patients with type 1 diabetes (T1D) underscore its similar safety and efficacy to the reference insulin glargine.

This month, AbbVie filed suit against biosimilar developer Sandoz over its proposed adalimumab (Humira) biosimilar. The suit was filed in the District of New Jersey and alleges infringement under the Biologics Price Competition and Innovation Act.

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.