News

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration, despite the fact that bevacizumab does not have a marketing authorization for this indication.

The Association of the British Pharmaceutical Industry, a trade group representing UK drug makers, announced that it has reached a voluntary deal with the UK government that involves capping the growth of sales of brand-name drugs to the National Health Service at 2% per year in exchange for faster product launches and speedier appraisals by the National Institute for Clinical Excellence (NICE).

The European Commission, in conjunction with the Organization for Economic Co-operation and Development, has released its Health at a Glance: Europe 2018 report which highlights the need for and value of generic and biosimilar products.

The proposed rule would allow plans to make broader use of prior authorization and step therapy for drugs—including drugs in protected classes—that are covered under Part D.

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

Last week, Biosimilars Canada, a trade organization representing Canada’s biosimilar developers including Sandoz, Mylan, and Fresenius Kabi, among others, announced that it had chosen Innomar Strategies to be the preferred provider for the Biosimilars Canada Patient Support Program platform.

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Nielsen, a global measurement and data analytics company, recently revealed that direct-to-consumer healthcare advertising has reached 75% of US cancer survivors on television.

Biosimilar developer Alvotech and Fuji Pharma have entered into a partnership agreement for the commercialization of Alvotech’s entire pipeline of biosimilars in Japan, the companies announced this week.

Mylan and Biocon jointly announced earlier this month that their biosimilar insulin glargine, sold as Semglee and referencing Lantus, has launched in the United Kingdom.

A recent study sought to clarify factors that could predict therapeutic response to infliximab in Japanese patients with Crohn disease (CD), and found 4 key indicators that may predict response in clinical practice.

The Center for Biosimilars® recaps the top news for the week of November 19, 2018.

The FDA recently announced that it approved a record-breaking number of generic drugs in October 2018.

Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.

Bevacizumab, an anti–vascular endothelial growth factor treatment for which 1 biosimilar has been approved to date, has been shown to improve quality of life for patients with glioblastoma—and to delay disease progression—but has not prolonged patients’ overall survival. However, recent research suggests that using 4 older drugs together with bevacizumab could provide a more effective treatment protocol.

While the United Kingdom (UK) was a slow adopter of biosimilars compared with many of its European counterparts, recent years have seen a steady uptick in biosimilar use. A new qualitative study, using semistructured interviews with healthcare providers in the United Kingdom’s West Midlands region, sought to assess attitudes toward biosimilars in the clinical specialties of diabetes, inflammatory bowel disease, and rheumatology.

Some studies have found that granulocyte colony-stimulating factor (G-CSF) therapies are underused for the prophylaxis of febrile neutropenia (FN) in Europe, but the widespread availability of cheaper biosimilar options has led to increased use. A new study, published in BMC Cancer, sought to examine the use of the biosimilar filgrastim, Zarzio, in relationship to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.

This month, Novartis submitted a letter to the FDA in support of a citizen petition that Pfizer filed in August.

Sandoz, a subsidiary division of Novartis, has launched its infliximab biosimilar, Zessly, in Germany. The launch brings the number of infliximab biosimilars available in Germany to 3.

Results of a recent survey demonstrate that Asian physicians are less confident in using biosimilars than their European peers are.

Denmark’s national authorities have confirmed to The Center for Biosimilars® that AbbVie's Humira did not offer the lowest price for adalimumab in either of 2 national tenders.

In many regulatory territories, patients with Crohn disease (CD) who lose response to adalimumab at a dose of 40 mg given every other week may be given an escalation to 40 mg every week. However, in Japan, where adalimumab is typically administered by a healthcare provider rather than by the patient, a study investigated the efficacy, safety, and pharmacokinetics (PK) of adalimumab after a dose escalation to 80 mg every other week as a means to reduce the need for additional patient appointments.

During the 83rd Annual Scientific Meeting of the American College of Gastroenterology, researchers from the United Kingdom reported on yet another large, nonmedical switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), this time in the Pennine Acute Hospitals Trust.

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.

Samsung BioLogics, parent company of the biosimilar development business Samsung Bioepis, has been fined by the Republic of Korea’s financial regulatory body, The Securities and Futures Commission, after the commission ruled that Samsung had committed fraud.

Three quantification assays optimized for therapeutic drug monitoring of Remicade can be used to monitor levels of the infliximab biosimilar Flixabi (sold in the United States as Renflexis).

The Center for Biosimilars® recaps the top news for the week of November 12, 2018.

Rituximab is frequently used off-label as a treatment for relapsing-remitting multiple sclerosis (MS) because it induces the depletion of circulating B-cell and T-cell lymphocytes and targets CD20 protein in B cells that are responsible for the production of antibodies.

Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).