Development

Bio-Thera Solutions began a phase 1 trial for its mepolizumab biosimilar candidate; Biocon Biologics licenses out 2 biosimilars to Yoshindo; and Alvotech and STADA Arzneimittel launch Hukyndra, an adalimumab biosimilar, in Switzerland.

St John Skilton, PhD, vice president of product strategy and marketing at Protein Metrics, takes a deep dive into how the development of biosimilars is evolving and how tools, such as mass spectrometry, can help companies keep up with advancing technology.

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.

Two posters presented at the annual conference of the American Academy of Ophthalmology (AAO) demonstrated positive phase 3 results for proposed biosimilars that reference blockbuster drug, Eylea (aflibercept).

In a review article discussing the role of biosimilars in neovascular retinal diseases, the authors concluded that biologics have significantly improved patient outcomes, noting that vascular endothelial growth factor inhibitors are now considered first-line treatments.

A phase 1 study in Japan found similar pharmacokinetic (PK) and glucose pharmacodynamic (PD) parameters between the biosimilar SAR342434 (SAR-Lis, Sanofi) and the Japan-reference insulin lispro (Humalog) in healthy male participants.

As Alvotech’s biosimilars are included in a commercialization deal in the Philippines, the company hits a setback in its quest for FDA approval of its adalimumab biosimilar; the FDA gives EpiVax a $2 million grant to run immunogenicity testing for biosimilars.

A phase 1 study of an enoxaparin sodium biosimilar Cloti-Xa established similar pharmacodynamics and pharmacokinetic profiles with the reference product (Clexane, Lovenox) in healthy participants.

In a recent paper, Sarfaraz K. Niazi, PhD, argues that getting rid of clinical efficacy testing for biosimilars could realign testing ethics with current guidelines, save companies money on development, and improve data sensitivity.

Celltrion Healthcare released positive data for an ustekinumab biosimilar, and Samsung Bioepis announced long-term safety and efficacy results for its adalimumab biosimilar.

Thanks to the success of its adalimumab biosimilar in Canadian and European markets, Alvotech’s revenues reached over $40 million during the first 6 months of 2022, nearly 20 times more than its revenue from the same period in 2021.

In advance of the World Health Organization (WHO) updating its guidelines for biosimilar development, a review article concluded that comparative clinical efficacy and safety studies may not be helpful for the evaluation of biosimilars.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, describes the pharmacoeconomics of biosimilars and the savings potential for practices and payers if they prioritize greater biosimilar adoption.

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.

Celltrion Healthcare set its sights on obtaining an interchangeability designation for its adalimumab biosimilar, and Formycon released positive findings from a phase 3 trial involving its ustekinumab biosimilar.

A phase 1 study compared pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity between SB12, a proposed eculizumab biosimilar, and EU and US reference products (Soliris) in healthy adults.

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

Results from a phase 3 trial suggested similar efficacy and safety of the denosumab biosimilar candidate Arylia (AryoGen Pharmed) to the reference product (Prolia) in postmenopausal osteoporosis.

Posters from the American Society of Clinical Oncology’s annual meeting showed the safety and efficacy of a trastuzumab biosimilar and a denosumab biosimilar in different types of cancer.

A letter penned by Sarfaraz K. Niazi, PhD, advocating for the banning of animal testing requirements for biosimilar development was published in Science, suggesting the journal has softened to the idea that animal testing may not be as useful as originally thought.

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explains the difference between biosimilar interchangeability and substitution and weighs in on whether switching studies are necessary.

As Alvotech announced that dosing of patients with its aflibercept biosimilar candidate has begun, Viatris announces its third recall for a batch of its insulin glargine biosimilar over missing labels.

In the first human study of Shanghai Henlius Biotech's pertuzumab biosimilar candidate (HLX11), investigators found similar pharmacokinetic (PK), safety, and immunogenicity profiles between the biosimilar and the reference product (Perjeta).

Shanghai Henlius Biotech announced the commencement of a phase 3 trial for its denosumab biosimilar (HLX14) referencing Xgeva in postmenopausal patients with osteoporosis with a high risk of fracture.

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

Formycon’s completed acquisition of 2 biosimilar assets and start of development for 2 others provide hope for investors as the company announced some expected losses during the first quarter of fiscal year 2022.

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explores the complicated world of phase 3 trials for biosimilars to answer the question of whether they are truly needed for establishing biosimilar safety and efficacy.

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

Data showing the clinical outcomes of Samsung Bioepis’ biosimilar referencing Humira (adalimumab) were shared at the European Congress of Rheumatology’s annual meeting, EULAR 2022.

With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering a new phase of biosimilar use.