News

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).

Recently, plaintiff Genentech and defendant Pfizer filed a collective stipulation and proposed order of dismissal of a patent infringement lawsuit over Genentech’s reference trastuzumab product, Herceptin.

Amgen and Entera Bio have announced that they have entered into a research collaboration and license agreement to develop orally administered formulations of biologic drugs.

On Tuesday, the FDA took significant steps toward a long-awaited transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

Yesterday, 339 patient, provider, and caregiver groups, on behalf of the Part B Access for Seniors and Physicians Coalition, sent a letter to Congress encouraging lawmakers to block the implementation of the International Pricing Index (IPI) model that was announced last month.

Since the advent of biosimilar filgrastim, patient access to the prophylaxis of chemotherapy-induced febrile neutropenia has improved in many regulatory territories, yet concerns remain about whether the United States is keeping pace with the rest of the world in biosimilar uptake and associated patient access.

Pfenex announced this week that it submitted to the FDA a New Drug Application (NDA) for its PF708, a teriparatide follow-on referencing Eli Lilly’s Forteo for the treatment of osteoporosis.

In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies.