Kelly Davio

Approval of biosimilars in indications for which they were not studied directly in phase 3 clinical trials relies on the extrapolation of indications, a concept that is scientifically justified but, nevertheless, has generated some concerns among clinicians. In the case of biosimilar infliximab CT-P13 (Inflectra, Remsima), some gastroenterologists have voiced a lack of confidence in the biosimilar for the treatment of inflammatory bowel disease, including Crohn disease (CD) and ulcerative colitis. Now, head-to-head study, published in The Lancet, has produced data that may help allay those worries.

Daiichi Sankyo has announced that it is accelerating its Biologics License Application (BLA) for DS-8201, [fam-] trastuzumab deruxtecan for the treatment of patients who previously received ado-trastuzumab emtansine (Kadcyla), to the first half of 2019.

Patient access to treatment has improved in many countries since the advent of biosimilars, where access to biologic treatments is variable among nations and faces restrictions based on limitations to healthcare resources. During the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of healthcare providers discussed this expanded access as well as other benefits that accrue to patients when biosimilars generate competition in the biologics market. They also considered lingering hurdles with provider education.

During the second day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a panel of experts discussed the current state of the regulatory landscape and considerations for tailoring clinical programs in the years ahead.

During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a group of experts addressed successes, challenges, and learnings from biosimilar procurement processes.

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

The FDA's updated guidance on the naming of biologics, biosimilars, and interchangeable products has caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.

Ned Pojskic, leader of pharmacy and health provider relations at the not-for-profit Green Shield Canada, the fourth largest private payer in Canada, discussed his organization’s efforts toward broad biosimilar adoption.

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Steinar Madsen, MD, director of the Norwegian Medicines Agency (NoMA) and self-described “spiritual father” of the NOR-SWITCH study, gave a presentation on the sustainability of the biosimilars market in Europe.

Often left out of the discussion about switching to biosimilars is the perspective of a particularly key stakeholder group: patients. During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21-22 in Porto, Portugal, Francois-Xavier Frapaise, MD, principal of F.-X. Frapaise Consulting, sought to describe current challenges and emerging solutions in gaining patients’ trust in biosimilars and suggested that biosimilars can be an opportunity to “resuscitate the social contract.”

During the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, João Gonçalves, PhD, group leader and principal investigator at Research Institute for Medicines in Portugal, discussed ways in which biosimilar developers can anticipate—and avoid—issues with immunogenicity.

While much attention is paid to the US and European biosimilars markets and the benefits that biosimilars could accrue for patient access and cost reduction, other large regulatory jurisdictions, including those with limited healthcare resources, could also benefit from these products. However, bringing biosimilars to countries outside of European Medicines Agency (EMA) or FDA authority has its unique challenges.

Nikolai C. Brun, MD, PhD, chief medical officer and director of the division of medical evaluation and biostatistics at the Danish Medicines Agency, shared how his national agency has actively worked to adopt and benefit from biosimilars, and provided a clear reminder of the fact that biosimilar uptake does not occur without concerted effort on the part of stakeholders.

During the first day of the BioTech Pharma third annual Biosimilars and Biologics Summit, held March 21 to 22 in Porto, Portugal, Barbara Valenta-Singer, MD, chief medical officer of biosimilars at Fresenius-Kabi SwissBioSim, gave an expert perspective on the past 10-plus years of experience with biosimilars in the European and US contexts.

A class action lawsuit has been filed by United Food and Commercial Workers Local 1500 (UFCW Local 1500) against AbbVie for alleged use of a patent thicket to maintain a monopoly for its brand-name adalimumab, Humira. The complaint also alleges that AbbVie and a number of its biosimilar competitors colluded to divide the market for adalimumab between Europe and the United States.

Although rituximab does not carry an indication for the treatment of neurological disorders, the drug is widely used off-label as a therapy for B-cell–mediated disorders like multiple sclerosis (MS). Given the fact that rituximab has not been approved in these indications, however, data that reflect its safety and efficacy—particularly in patient populations for whom data are particularly scarce—are crucial.

In a paper published last week in ACR Open Rheumatology, researchers reported that although patients had some concerns about safety and efficacy, overall, they were satisfied with the switch to a biosimilar.

The United Kingdom’s Competition and Markets Authority has closed an investigation into an alleged anticompetitive discount scheme related to brand-name infliximab, Remicade.

On Wednesday, the House Committee on Energy and Commerce held a Health Subcommittee legislative hearing on lowering the cost of prescription drugs. The 7 bills that were the subject of the hearing include several items of legislation that have long waited for congressional action as well as new proposals to address the need for increased competition.

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

Celltrion, maker of biosimilar infliximab CT-P13 (Remsima, Inflectra), has recently submitted an application to the European Medicines Agency for a subcutaneous formulation of the biosimilar.

The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.