Development

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.

Real-world clinical data compiled for patients with autoimmune disorders were presented at EULAR 2021.

An antibody conjugate, Ujvira combines the cancer cell growth–fighting properties of trastuzumab with the cytotoxic capability of emtansine.

Investigators evaluated both biosimilar vs originator savings and savings from earlier use of a lower-cost adalimumab biosimilar (Amgevita).

A Canada study of the filgrastim biosimilar Grastofil demonstrated equivalence to Neupogen in candidates for autologous stem cell transplantation (ASCT), an extrapolated use.

A second class of biosimilars that are considered "interchangeable" could set biosimilars back in terms of acceptance, according to Albert Kim, MBA.

With COVID-19 on the retreat, Coherus BioSciences sees the advantage wearing off for Amgen's pegfilgrastim injector kit.

When it comes to biologics, there is a constant push and pull over patent rights. Some believe this is part of a healthy market-driven economy. Others are skeptical.

After being sued for allegedly stealing adalimumab process information, Alvotech fires back.

Allen Lising, managing director of Xcenda’s FormularyDecisions, explains how stakeholders are using pre-approval information to make business decisions.

The latest e-book from The Center for Biosimilars® offers insightful content on patient education, biosimilar development, and regulatory issues.

"Shocked" by the threat of competition, originator manufacturers start raising prices long before rival products appear on the scene, investigators found.

Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Incremental gains in the number of approved biosimilars and no new biologic categories were the low points, but uptake and improved patient access were highlights of 2020.

The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape.

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.

The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.

The reference product rights holder contends that Centus has not provided complete information about its manufacturing processes related to FKB238, the proposed biosimilar.

The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.

Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars (OTBB), highlighted the ways the FDA is working to remove blocks and wedges hindering biosimilars.

The company has multiple biosimilar products on the worldwide market and in development; in 2019, it gained World Health Organization precertification for a trastuzumab biosimilar (Ontruzant).

Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but modifications to regulatory policy could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.

With a sizeable round of fresh capital, Alvotech hopes to bring monoclonal antibodies and fusion proteins through the development pipeline.

Shanghai Henlius Biotech will share development and distribution of its bevacizumab biosimilar candidate HLX04 with Zhuhai Essex and Essex Bio-Investment.

Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.