For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...

Arizona Gov. Doug Ducey (R) late last week signed into law a bill that would restrict which types of biosimilars pharmacists in the state can substitute biologics for. Hailed as a victory by industry group BIO , the law, like the 20 similar laws passed before it , is helping to create a patchwork of regulations governing how biosimilars are dispensed, even before biosimilars have hit the market en masse in the US. In the EU, however, the uptake of biosimilars, much l...

The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars. The group of nonprofits and other stakeholders, spearheaded by the Alliance for Safe Biologics, requested in a letter that FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used wi...

The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...

With 56 new biosimilars in clinical development, IMS Consulting Group says in a new report that the biologic competitors could save health systems across Europe and the US as much as $110 billion through 2020. But the savings for both regions will vary considerably as payers have adopted a variety of approaches to encourage physicians to prescribe biosimilars, motivate manufacturers and require certain clinical evidence to support the prescribing of these treatments. Fo...

India’s Central Drugs Standard Control Organization on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies. The new document is a slight tweak of previous guidance issued in 2012 , but includes several important changes that are now up for discussion through 30 April. India's biosimilars market currently includes ei...

Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...

The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing. The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though th...

The guidance agenda for the next fiscal year from the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) reveals a lot of new advice on generics, pharmaceutical quality, off-label communications and other recommendations carried over from 2015, particularly on the implementation of the Drug Supply Chain Security Act (DSCSA). The 15 categories of guidance documents planned for 2016 range from advertising (including a potentially controv...

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked. On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements coul...

The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...

The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust. The current legislative authority for the Biosimilar User Fee Act (BsUFA) expires in September 2017, so FDA has to work with a number of stakeholders (industry, patients, academia, etc.) to devise ...