News

AffaMed Therapeutics announced this week that it has received a Clinical Trial Application (CTA) approval from Chinese regulators to conduct a phase 3 clinical trial of Samsung Bioepis’ biosimilar trastuzumab, SB3.

An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.

While biosimilars approved by regulators have been shown to have no clinically meaningful differences from their reference products, this week, during the San Antonio Breast Cancer Symposium, held in San Antonio, Texas, researchers will report reassuring data for biosimilar trastuzumab, Ogivri, showing that the combination of the biosimilar with pertuzumab is highly similar to the combination of the reference drug with pertuzumab.

During this week’s 61st meeting of the American Society of Hematology (ASH), researchers reported on eculizumab, a prospective biosimilar, and the long-acting ravulizumab.

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Celltrion and Teva’s biosimilar rituximab, CT-P10, Truxima, recently launched in the United States. The product is the first rituximab biosimilar to become available to US patients, and during this week’s 61st meeting of the American Society of Hematology (ASH), 2 research teams presented data that highlight the biosimilar’s safety and efficacy in patients with lymphoma.

As yet, there exists no consensus as to whether proactive or reactive monitoring is the most appropriate approach in patients with inflammatory bowel disease (IBD) who receive infliximab therapy.

Israel-based Kamada Ltd announced this week that it has entered into an agreement with Iceland-based Alvotech to commercialize 6 biosimilar products in Israel once the products gain local regulatory approval.

The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.

NeuClone did not specify whether it intends to move to a phase 3 clinical trial for the biosimilar. In fact, in its statement on the phase 1 results, the company noted that phase 3 trials are not required to achieve regulatory clearance.

Interestingly, nocebo effects may also be induced by exposure to information shared online, through social media, through drug advertisements, and advertised descriptions or warnings about health-related conditions. The effect can be profound; the authors said negative expectations underlying nocebo phenomena have been shown to alter activity in certain regions of the brain.

The Center for Biosimilars® recaps the top stories for the week of December 2, 2019.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, said this week that the China National Medical Products Administration (NMPA) has approved its Investigational New Drug (IND) application to initiate a phase 1 clinical study to compare the pharmacokinetics and safety of BAT2206, a proposed ustekinumab biosimilar, to the reference Stelara in healthy volunteers.

While there is no question that falling prices that come with competition are cause for optimism in the United States, which is burdened by rising drug costs, some experts from Europe caution that a focus on price alone misses key reasons to use biosimilars.

Researchers from biotech company Tetra Therapeutics have reported that, in their retrospective population-based study of 56 million patients with inflammatory diseases, use of anti–tumor necrosis factor (anti-TNF) agents was linked with a reduced risk of Alzheimer disease.

Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.

Drug developer Biocad received approval for its rituximab biosimilar, BCD-020 (Acellbia) in Russia in 2014, and since that time, the drug has been launched in Russia and in multiple other markets around the world. While Biocad has not specified whether it plans to pursue regulatory approval for the biosimilar in the European Union, the company has announced ambitions to enter the EU market with some of its products, and researchers have published new data for the biosimilar in both oncology and rheumatology indications.

Amgen and pharmacy benefit manager (PBM) Abarca this week announced that they have entered into an outcomes-based contract for brand-name etanercept, Enbrel.

Trade representatives for Canada and Mexico met last week over the ratification and implementation of the United States–Mexico–Canada Agreement (USMCA), and press reports say that the Trump administration is considering acceding to Democrats’ demands to reduce patent protections for reference biologics in order to get the pact through Congress.

The Federal Circuit, in Arthrex, Inc v Smith & Nephew, Inc, ruled that the appointment of Administrative Patent Judges (APJs) at the Patent Trial and Appeal Board (PTAB) violated the Appointments Clause of the US Constitution, and held that APJs could be removed from office without cause. Absent a dramatic ideological shift in the PTAB, however, this decision likely will have little impact on how follow-on biologics developers use inter partes review (IPR).

In Crohn disease (CD), anti–tumor necrosis factor therapies like adalimumab have provided an alternative to long-term corticosteroid therapy and have reduced the need for many patients to have surgical interventions. It has been proposed that early treatment with biologics may lead to better outcomes and fewer complications—like strictures and fistulae—and findings from a recent study support that assertion.

HR 3 proposes targeting for negotiation those drugs that consume a large share of the healthcare budget and that have limited biosimilar or generic competition. Writing in a perspective article in The New England Journal of Medicine, Peter B. Bach, MD, MAAP, a noted critic of high drug prices, proposed a different set of targets.

With debate and argument over what is to blame for high drug pricing, this report sought to examine the executives’ reasoning and attitudes behind pricing decisions.

The government should ensure that practices that unfairly inhibit biosimilars competition do not occur. We do not want to discourage normal competition. Biologics are not a natural monopoly, and competition is feasible, as demonstrated around the world. Biologics have provided great benefits; nevertheless, some policies can be adopted to maintain incentives for innovation but still allow increased competition from biosimilars.

The European Commission has released a new report that highlights the role that biosimilars and generics will have in the wellbeing of European healthcare systems in the years ahead.

Mylan and Biocon have announced that their biosimilar trastuzumab, Ogivri, has become commercially available in the United States. The biosimilar, referencing Herceptin, is now available in a 420-mg multidose vial and a 150-mg single-dose vial.

Universal access to affordable essential medicines remains an unmet goal, and while the World Health Organization has been attempting to address this problem through prequalification of drugs like insulin to help ensure access for patients in low-resource areas, costs for many products remain prohibitive.

Data on the safety and efficacy of biosimilar infliximab CT-P13 (Inflectra, Remsima) in treating inflammatory bowel disease (IBD) continue to accrue, in both adult patients and in pediatric patients, and a study from Finland adds to that body of knowledge, while another study in pediatric patients shows that Janus kinase (JAK) inhibitors may be an option for those who do not respond adequately to infliximab or other biologic treatment.

During November, biosimilar developers announced a spate of new business agreements and acquisitions. November also saw biosimilars approved and launched, and innovator products’ sales slipping.