News

Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.

The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics.

Despite progress in the successful treatment of patients with rheumatoid arthritis (RA) who are using conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs), a Greek study has found that a considerable number of patients are still not achieving low disease activity (LDA) despite having been treated following established recommendations for RA therapy.

Last week, the FDA issued a 32-page Form 483 to Mylan after a 5-week inspection of its manufacturing plant in Morgantown, West Virginia. The FDA cited 13 inspection observations, including failure to follow proper quality control protocols, lack of adequate cleaning of utensils and equipment, and ineffective laboratory controls and sampling, among others.

An analysis by consumer website GoodRx concluded that the price people pay for generic drugs at the pharmacy varies greatly based on where they live.

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II).

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

The new rule imposes a 10% fee-for-service cut on any provider who doesn’t opt into a managed-care network, and rural hospitals are especially concerned about the financial losses the change may cause.

Last week, the European Specialist Nurses Organisations (ESNO) released a document aimed at assisting nurses in the management of switching a patient from a reference biologic to a biosimilar.

A recent study looked to evaluate the association between infliximab trough levels, response to treatment, and quality of life in a cohort of Brazilian irritable bowel disease (IBD) patients.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

A preliminary study among patients with rheumatoid arthritis (RA) in Norway who were switched from originator etanercept to its biosimilar (SB4) for nonmedical reasons found that patients had good tolerance for the switch to the biosimilar, with no impairment in disease measures.

Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.

The FDA continues to update its list of off-patent, off-exclusivity drugs without approved generic competitors to meet the organization's broader goals defined under the Drug Competition Action Plan.

The presence or absence of insurance coverage for trastuzumab treatment was the strongest predictor of trastuzumab therapy use in Chinese patients.

Eales disease (ED) is a common, idiopathic, inflammatory retinal vasculitis that particularly affects young adults. Current treatments available for ED include corticosteroids, laser photocoagulation, retinal cryotherapy, and surgery, but a recent study found that using intravitreal bevacizumab injections may produce better outcomes and reduce the need for surgery.

Primary sclerosing cholangitis (PSC) is a chronic, immune-mediated, progressive biliary disease that is closely associated with inflammatory bowel disease (IBD). PSC has no cure, and up to 40% of cases eventually require patients to receive liver transplants. Given the efficacy of biologics in treating IBD, the potential to treat PSC with these same drugs is a matter of interest for healthcare providers.

Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.

Here are the top 5 biosimilars articles for the week of June 25.

Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology concluded that patients’ attitudes and level of satisfaction with switching to a biosimilar for etanercept or infliximab was associated with their level of health literacy, defined as being given sufficient and necessary information concerning their health.

Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.

New International League of Associations for Rheumatology (ILAR) recommendations are now available for the treatment of patients with psoriatic arthritis living in resource-poor regions, including Central and South America and Africa.

The study, conducted in 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept, found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up.

Researchers have reported the development of CubiCAR architecture, which has the potential to improve the safety of chimeric antigen receptor (CAR) T-cell immunotherapies for a broad range of patients with cancer.

Lupin pharmaceuticals has entered into an agreement with Nichi-Iko for the distribution, promotion, and sale of its proposed biosimilar etanercept, YLB113, in Japan.

Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologic drugs, including anti–tumor necrosis factor (TNF) agents, are often prescribed in cases in which patients fail to respond adequately to methotrexate.

Catch up on the week’s top rheumatology, gastroenterology, neurology, clinical practice, advocacy, regulatory, policy, and business news from the world of biosimilars.