News

Innovent Biologics said based on success of ORIENT-32, China's National Medical Products Administration (NMPA) has approved sintilimab in combination with bevacizumab biosimilar (Byvasda) in front-line unresectable hepatocellular carcinoma.

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.

Here are the top 5 biosimilar articles for the week of June 21, 2021.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has favored marketing authorization for the ranibizumab biosimilar (Byooviz, SB11) based on phase 3 study findings.

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.

Cigna said it will push biosimilar forms of infliximab onto the preferred list and reward patients who make the switch.

Investigators determine that converting at least 2 patients with metastatic breast cancer to a trastuzumab biosimilar could generate savings enough to treat a third patient.

Diverse findings on biosimilar safety and savings were presented at the American Society for Clinical Oncology (ASCO) 2021 Annual Meeting.

Pay-for-delay settlements between drug companies are better regulated than in the past and are in danger of being overregulated, one panelist said.

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).

Real-world evidence from Poland and Brazil confirms comparable safety for the trastuzumab biosimilars Kanjinti and Zedora in the breast and gastrointestinal cancer settings.

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

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.

Here are the top 5 biosimilar articles for the week of June 14, 2021.

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.

The Mississippi attorney general takes on major insulin producers and pharmacy benefit managers in a suit alleging a massive pricing scheme to gouge patients and payers.

The “winner-takes-all” tender process for biosimilar procurement in the European Union runs the risk of driving competitors out of the market, authors of a new survey contend.

Same-day pegfilgrastim to combat febrile neutropenia in conjunction with myelosuppressive chemotherapy (CTX) is safe, investigators conclude.

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.

Postmarketing retrospective studies of the rituximab biosimilar (CT-P10, Truxima) demonstrated comparable safety and efficacy for treatment of diffuse large B-cell lymphoma (DLBCL).

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.

Here are the top 5 biosimilar articles for the week of June 7, 2021.

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally.

Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi.

Reverse switching occurs when patients transitioned to or initiated on a biosimilar are changed to an originator product, often because of a perceived failure in the biosimilar therapy.