Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.
New Zealand’s Pharmaceutical Management Agency (Pharmac) has proposed to stop funding Janssen’s reference epoetin alfa product in favor of a biosimilar.
Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.
The change, which would be applicable until June 30, 2022, follows a May 2018 request for proposals from drug makers to supply epoetin alfa.
Click to read more about Binocrit.
Pharmac, which was established in 1993 to help rein in high drug costs for the nation’s public health system, manages New Zealand’s schedule of government-subsidized pharmaceuticals, a list that comprises approximately 2600 medicines used in public hospitals.
Whenever possible, Pharmac awards a sole tender for a single brand of a product to be reimbursed, and patients who wish to use a different product, such as a reference product for a biosimilar, must pay the full price of their preferred drug. The tendering process, says Pharmac, generates approximately $30 million in savings each year, and these savings are used to widen access to already subsidized medicines.
The agency has thus far shown strong support for the use of cost-saving biosimilars in the tendering process; in August 2012, Pharmac announced a decision in which it named Sandoz’ biosimilar filgrastim, sold as Zarzio (and sold in the United States as Zarxio), the sole supplier of filgrastim for the nation. Then, in 2014, when biosimilar infliximab (Inflectra) became available in New Zealand, Pharmac used availability of the lower-cost biosimilar to negotiate a 30% cut to the list price of the reference infliximab, Remicade. The deal with Remicade’s maker, Janssen, will save the country an estimated $25 million (approximately USD $16 million) over a 5-year term.
Pharmac is open to public comments on the proposed change to its epoetin alfa supply until September 10, 2018.
Senators Introduce Bipartisan Legislation to Protect Skinny Labeling
January 2nd 2025To close out the year, 4 senators came together to introduce a new bipartisan bill to protect biosimilar and generic drug manufacturers from patent litigation when obtaining “skinny label” approvals for their products.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
How Vertical Integration Drives Innovation and Access in Biosimilars
December 27th 2024Elie Bahou, PharmD, highlights how vertical integration in the biosimilar industry streamlines costs, improves supply reliability, accelerates market adoption, and enhances patient access, while emphasizing the value of collaboration, quality control, and value-based contracts for sustainable health care delivery.
13 Strategies to Avoid the Nocebo Effect During Biosimilar Switching
December 18th 2024A systematic review identified 13 strategies, including patient and provider education, empathetic communication, and shared decision-making, to mitigate the nocebo effect in biosimilar switching, emphasizing the need for a multifaceted approach to improve patient perceptions and therapeutic outcomes.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.