News

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

While the American College of Rheumatology praised the FDA for considering ways to reduce regulatory burden, the organization called on the FDA to focus on 6 “minimum components of review and oversight” for biosimilars.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

Our latest infographic provides 3 key takeaways from the American Society of Hematology's (ASH) 59th Annual Meeting and Exposition.

This week, Leah Christl, PhD, associate director for therapeutic biologics, Center for Drug Evaluation and Research (CDER), FDA, and Sue Lim, MD, medical officer at the FDA’s Office of New Drugs, held a webinar to discuss the regulatory framework for biosimilars as well as the development and approval process for these drugs.

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.

A recently published systematic literature review sought to compare the effects of down-titration of biologics compared with standard dosing on clinical efficacy and health-related quality of life, and to evaluate the impact of decreased doses on the cost of RA treatment.

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

Advances in research have led to increased therapeutic options for patients with cancer, but these drugs come at a substantial cost; high out-of-pocket costs pose a significant barrier to treatment initiation for patients with cancer, according to a new, retrospective claims-based study.

No differences in drug levels or disease activity were found when adult patients with inflammatory bowel disease (IBD) were switched from originator infliximab (Remicade) to a biosimilar infliximab (Inflectra) as part of routine care, according to the results of a Dutch study.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

A new report from calls for big changes in how US pharmaceuticals are priced, promoted, and sold so that treatments are more affordable and equally available to all Americans, as market mechanisms that would usually moderate prices have been blunted or eliminated.

A newly published study finds that subcutaneous administration of trastuzumab produces substantial time savings for healthcare providers and patients, as well as reduced costs.

Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.

The Association for Accessible Medicines (AAM), a trade association that represents biosimilar and generic drug makers, has filed an amicus brief in support of Mylan, Teva, and Akorn in their inter partes review (IPR) proceeding against Allergan, owner of embattled patents covering cyclosporine ophthalmic emulsion (Restasis).

The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.

CVS Health has agreed to purchase Aetna, a transaction that would combine CVS’s retail pharmacies with Aetna’s health insurance company in a $69 billion deal that could create a company with annual revenue of $240 billion, and that has the potential to reshape the US healthcare system.

Lucentis (ranibizumab) faces oncoming competition from 4 companies that are developing proposed biosimilars.

Russian biosimilar developer Biocad has announced that it will begin manufacturing its rituximab and bevacizumab biosimilars in Morocco. The 2 drugs, manufactured in partnership with Sothema Labs, will be sold in numerous markets in North Africa, including Morocco, Senegal, Gabon, and Cote d’Ivoire.

Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.

The Center for Biosimilars recaps the top 5 articles for the week of November 27.

The FDA has approved Mylan–Biocon’s trastuzumab biosimilar, MYL-1401O, referenced on Roche’s Herceptin. The drug will be marketed in the United States as Ogivri.

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

HHS has rescinded its approval of a major charity, Caring Voice Coalition, after the charity allowed pharma donors improper influence over the nonprofit.

Because biosimilars are relatively new to the United States, drug makers pursuing FDA approval for biosimilars seek additional information about the kinds and quantities of evidence that the agency uses to approve these therapies.

The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.

A recent report by the World Health Organization (WHO) showed that nearly 1 in every 10 drugs is falsified or substandard, and estimates the net worth of the industry for such drugs at nearly $30 billion.

This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.

A recent study was conducted to determine whether the concurrent use of denosumab with a biologic disease-modifying antirheumatic drug (bDMARD), such as adalimuab, etanercept, or infliximab, increases the risk of infection.