Development

Authors of an opinion piece suggest that a "reliance" approach to biosimilar approval could lead to global standards for acceptance that cut down on wasted review time and obsolete clinical investigation.

Sizeable savings per patient with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) were anticipated by a Medicare savings model.

A turning point for interchangeable biosimilars has arrived, as the first may be approved this year, but many questions about these agents have yet to be answered, according to Laura Sim, senior counsel for Amgen.

Tahir Amin, Dip LP, co-executive director of I-MAK, discusses some hot-button issues regarding the US patent system, including AbbVie’s alleged abuse of it, and his hopes for improvement.

Investigators report survival data for the bevacizumab biosimilar Byvasda with sintilimab (Tyvyt) in hepatitis B virus–associated advanced hepatocellular carcinoma (HCC).

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

Amneal Pharmaceuticals develops its biosimilar pipeline with mAbxience, Xcenda estimates biosimilar effect on originator pricing, and Magellan Rx Management touts oncology biosimilars savings.

Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market.

A technicality—inability to demonstrate harm—frustrated plaintiffs whose case threatened to sink not just the Affordable Care Act but also the Biosimilars Price Competition and Innovation Act (BPCIA), the pathway for biosimilars approvals.

Product differentiation, global partners, and a large suite of biosimilars in development are ways that Reykjavik, Iceland-based Alvotech expects to stay ahead of the competition.

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.