Deana Ferreri, PhD

Biosimilar market penetration has been slower than that of generics but the market share of biosimilars has grown over time, according to the authors of a study on biosimilar use in the European Union (EU).

Authors of a new in vitro study said Sanofi’s biosimilar SAR341402, approved in June 2020 by the European Medicines Agency for use in insulin pumps, had similar stability compared with the originator under stress conditions in their experiments.

A phase 1 clinical trial in China comparing the tocilizumab biosimilar candidate LZM008 to the reference product (Actemra) found pharmacokinetic (PK) parameters within the bioequivalence margins and similar immunogenicity and safety in healthy participants.

In a study including 2 years of real-world evidence (RWE), patients with rheumatoid arthritis (RA) who were switched from originator rituximab (Rituxan) to GP2013, a rituximab biosimilar, experienced positive results and maintained clinical outcomes.

The authors of what they say is the largest and longest follow-up study comparing the trastuzumab biosimilar SB3 to the reference product (Herceptin) in HER2-positive breast cancer found “no clinically meaningful difference” between the biosimilar and the reference product.

A review article investigating the use of bevacizumab biosimilars found that despite lingering concerns about their usage for extrapolated indications, bevacizumab biosimilars are regularly used in metastatic colorectal cancer (mCRC) even though clinical tests only evaluate them in patients with lung cancer.

A long-term follow-up of a phase 3 study comparing ranibizumab biosimilar SB11 to the reference product (Lucentis) in neovascular age-related macular degeneration (nAMD) found the similarity in efficacy end points reported early on was maintained through 52 weeks.

Authors of a single-center, real-world study in Turkey found that patients with diffuse large B-cell lymphoma (DLBCL) who received a rituximab biosimilar had similar overall survival to patients who received the originator. However, progression-free survival was longer in the originator group.

A real-world study in India compared the ranibizumab biosimilar Razumab to the originator (Lucentis) in patients with polypoidal choroidal vasculopathy (PCV), finding that the biosimilar had comparable clinical outcomes.

A review of real-world studies assessing patient-reported outcome measures of patients with rheumatoid arthritis (RA) found that although clinical outcomes were similar, patients taking a biosimilar were found to have higher discontinuation rates, possibly as a result of the nocebo effect.

More and more women are becoming pregnant while on anti–tumor necrosis factor (TNF) biosimilars used to treat inflammatory disorders. However, there is “little data” on the safety and effectiveness of biosimilars in pregnancy, according to authors of a recent retrospective study.

Increasing the use of biosimilars in Belgium will require realigning financial incentives and providing more information to medical professionals, according to authors of a study that proposed policy recommendations.

Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.

According to the authors of a cost-effectiveness analysis of treatments for hepatocellular carcinoma (HCC) in China, sintilimab plus a bevacizumab biosimilar could improve quality of life for patients, but at a higher cost than lenvatinib.

An analysis of US claims data found that prevalent (as of 2017) users of the infliximab reference product (Remicade) had the highest adherence rates compared to naïve originator users, prevalent biosimilar users, and naïve biosimilar users over 18 months of follow-up.

The proposed omalizumab biosimilar KA (Shanghai Taiyin Biotechnology) demonstrated similar analytical characteristics, in vitro biological activity, and pharmacology and toxicology in animals compared with the originator (Xolair), according to investigators.

A phase 3 analysis found that CKD-701, a ranibizumab biosimilar candidate developed by CKD Limited, has comparable clinical efficacy and safety with the reference product (Lucentis) in patients with neovascular age-related macular degeneration (nAMD).

A case study outlined a pediatric case of scalp and nail psoriasis, which was successfully treated with an adalimumab biosimilar and monitored with in vivo reflectance confocal microscopy.

A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the key drivers for biosimilar use to improve biosimilar uptake in France.

The “biosimilar-like” insulin glargine Basaglar was not less expensive for patients than the reference product, Lantus, concluded the authors of a retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets.

Despite recent steps taken by the FDA to streamline approvals and increase availability for biosimilars, biosimilar adoption has been slow and primarily driven by payers in the United States, signaling that more needs to be done to encourage adoption, according to experts at a virtual workshop hosted by the FDA and the University of Maryland.

A phase 1 study in China found that pharmacokinetics, safety, and immunogenicity were similar between the liraglutide biosimilar RD12014 and the reference product (Victoza) in healthy male participants.

The third in a series of clinical studies evaluating pharmacokinetics (PK) and pharmacodynamics (PD) of Biocon’s recombinant human insulins compared to their reference products, found PK and PD equivalence between the biosimilar insulin-70/30 and Humulin-70/30.

The VOLTAIRE-X randomized controlled trial determined the adalimumab biosimilar BI 695501 (adalimumab-adbm, Cyltezo; Boehringer Ingelheim) met the FDA’s criteria to be designated as interchangeable with the reference product (Humira).

A review explored the 3 main administration options for pegfilgrastim biosimilars, finding that providers should consider the ease and frequency to which patients will need to travel to a clinic for administration as well as their preferences when choosing a mode of administration.

The efficacy and safety of bevacizumab biosimilars in advanced non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (CRC) is comparable with the reference product (Avastin) and each other, according to a meta-analysis.

Authors of a plain-language summary of the VOLTAIRE-RA study examined how to help patients with rheumatoid arthritis (RA), their families, patient advocates, and health care professionals learn about potential new treatment options as the United States prepares for the introduction of adalimumab biosimilars.

Authors of a systematic review summarized the results of 21 published studies on the efficacy, safety, and cost-benefit ratio of trastuzumab biosimilars in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

A study from the Republic of Korea confirmed the safety and efficacy of Herzuma (CT-P16) in patients with heavily pretreated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

A placebo-controlled clinical trial found that rituximab biosimilar HLX01 in combination with methotrexate was successful at improving the clinical outcomes of patients with moderate-to-severe rheumatoid arthritis.