News

A recent systematic review of the literature reported on randomized controlled trials and nonrandomized studies on the use of granulocyte colony-stimulating factor therapies (G-CSFs) to reduce the incidence of febrile neutropenia, and found that short- and long-acting therapies, when dosed according to guidelines, have little difference in their efficacy.

A recent study sought to investigate the overall survival (OS) advantage of the addition of trastuzumab to chemotherapy for patients with human epidermal growth factor 2-positive early breast cancer.

This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

During the European Society for Medical Oncology’s Asia 2018 annual meeting, held in Singapore from November 23 to November 25, a research team presented an update on the clinical program for HLX02, a proposed trastuzumab biosimilar referencing Herceptin. The proposed biosimilar is being developed by the Chinese firm Shanghai Henlius Biotech.

This week, Japan-based Fuji Pharma announced that it has acquired a 4.2% stake in Alvotech, a biopharmaceutical company focused on the manufacturing of biosimilars, for roughly $50 million.

The Center for Biosimilars® recaps the top news for the week of December 17, 2018.

Researchers presented results from a simulation analysis that looked to identify the potential reduction in Medicare beneficiaries’ out-of-pocket costs through the use of biosimilar filgrastim-sndz (Zarxio, Sandoz) over the reference filgrastim at the 2018 San Antonio Breast Cancer Symposium held December 4-8, 2018, in San Antonio, Texas.

During last month’s European Society for Medical Oncology Asia 2018 annual meeting, held in Singapore from November 23 to November 25, researchers presented data demonstrating the biosimilarity of QL1101 with reference bevacizumab (Avastin).

CreakyJoints, a patient organization that is part of the Global Healthy Living Foundation (GHLF), has released the first edition of its patient guide to biosimilar medicines.

Under terms of the agreement, Cipla will have exclusive rights to distribute and market Prestige’s trastuzumab biosimilar (HD201) in selected emerging markets.

Sandoz has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

Mylan and Biocon have received final approval from the European Commission to market their trastuzumab biosimilar, Ogivri, referencing Herceptin.

Last week, Insurer Cigna and pharmacy benefit manager (PBM) Express Scripts overcame 2 hurdles to completing their $67 billion merger as New York and California insurance regulators signed off on the deal.

Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

Australian drug developer NeuClone has disclosed that it is currently developing a proposed pertuzumab biosimilar referencing Perjeta.

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

Johnson and Johnson (J&J) recently filed a motion to dismiss in the antitrust claim brought against the company by Walgreen and Kroger in regard to sales of J&J’s reference infliximab product, Remicade. In early December, the District Court for the Eastern District of Pennsylvania denied the motion.

The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

Yesterday, 4 senators introduced a bill on the Senate floor that would allow HHS to block drug price increases that it deems as “excessive.”

The Center for Biosimilars® recaps the top news for the week of December 10, 2018.

The sluggish acceptance of biosimilars in the United States has often been compared to that of the European Union, where biosimilars took a more accelerated course. When looking at the United States, however, one cannot overlook a key difference between its healthcare structure and that of many other countries: payers.

In its annual preview of the landscape for pharmaceuticals, Vantage predicted that 2019 will be a year of shakeups for the industry, with biosimilars potentially playing a substantial role.

Pfizer disclosed that it would increase the price of 41 drugs; 37 drugs will see price increases of 5%, 1 drug by 9%, and 3 drugs by 3% on January 15, 2019. The announcement was met with pushback from politicians who have been vocal about drug pricing concerns.

Second-generation anti–tumor necrosis factor (TNF) agents, etanercept, certolizumab, and golimumab, demonstrated a stronger neutralizing effect toward TNF versus first-generation anti-TNF agents, infliximab and adalimumab.

Chinese biologics developer Innovent has announced that its proposed bevacizumab candidate, IBI305, has met its primary end points in 2 randomized, head-to-head clinical trials that compared the biosimilar to the brand-name bevacizumab (Avastin).