News

This week, the US Court of Appeals for the Federal Circuit affirmed a district court decision against Pfizer subsidiary Hospira related to an epoetin alfa biosimilar.

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

No biosimilar adalimumab launches are currently announced for the US market prior to 2023 as a result of patent settlements struck between biosimilar developers and Humira’s maker, AbbVie, and new data show that innovative biologics currently being developed may be able to provide superior benefits versus the older adalimumab product that may make biosimilars of this therapy less appealing treatment choices.

Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Pfizer’s biosimilar adalimumab referencing Humira. The product, which Pfizer proposes to market under the name Amsparity, will now be reviewed by the European Commission before it receives final marketing authorization.

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.

The Center for Biosimilars® recaps the top stories for the week of December 9, 2019.

The House of Representatives, on Thursday, voted 230-192 to pass Speaker Nancy Pelosi’s, D-California, HR 3, the Elijah E. Cummings Lower Drug Costs Now Act, although the White House has already said it will veto the measure, assuming it is ever brought to the Senate floor and passes.

Given the availability of biosimilars of infliximab, etanercept, and adalimumab in multiple markets worldwide, and given the cost savings associated with the biosimilars, there is growing interest in switching patients receiving maintenance treatment for uveitis to these biosimilar options, but data in switching patients with uveitis have been limited.

During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar filgrastim could result in substantial savings.

Organizations are releasing patient education materials about what biosimilars are, what questions patients should ask, and other things they might want to know. The latest such example comes from Susan G. Komen, which recently released a guide to using biosimilars and biologics for breast cancer.

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.