Regulatory

A new Federal Trade Commission (FTC) staff report has found that, despite an increase in patent settlements concerning generic drugs, fewer settlements included the kinds of “pay-for-delay” provisions that are likely to be anticompetitive in nature.

Amid growing concern about the skyrocketing cost of insulin in the United States, the FDA held a public hearing this month about biosimilar insulins. This week on the podcast, we catch up with one of the experts who testified at the hearing: Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development at Vizient. He shares his thoughts with us on biosimilar insulins, interchangeability, biosimilar suffixes, and what milestones lie ahead as the United States approaches its 2020 transition of insulins to regulation as biologics.

Yesterday, the Senate Committee on Health, Education, Labor, and Pensions released bipartisan draft legislation aimed at lowering the cost of healthcare in the United States.

The Center for Biosimilars® recaps the top news for the week of May 20, 2019.

Europe has several lessons for the US biosimilar market, according to a pharmaceutical executive who spoke during ISPOR 2019.

Health Canada has approved Mylan and Biocon’s trastuzumab biosimilar, Ogivri, referencing Herceptin. The product, also approved in the United States, the European Union, and elsewhere, is the first biosimilar trastuzumab to be approved in Canada, and carries indications for HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

The FDA today released draft guidance on the design and evaluation of comparative analytical studies that are intended to support a demonstration of biosimilarity. A previous draft guidance document on statistical approaches to evaluate analytical similarity was withdrawn in June 2018.

The final guidance on interchangeability resolves some issues, creates many new issues and inquiries, and offers a path—albeit not a clear one—that is filled with scientific and clinical challenges.

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

The Center for Biosimilars® recaps the top news for the week of May 13, 2019.

During the inaugural Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, Francisco Ballester, MBA, head of the international region for Sandoz, discussed some of the key considerations that biosimilar developers face in emerging markets with The Center for Biosimilars®.

Set against a backdrop of rising concern about the cost of insulin, the FDA held a hearing about biosimilar insulins Monday, 10 months before the products transition in March 2020 from the Food Drug and Cosmetic Act to biologics under the Public Health Service Act.

The guidance explains that the data and information needed to meet the legal standard for interchangeability, which shows that the proposed interchangeable product can be expected to produce the same clinical result as the reference product in any given patient, will vary by case.

The FDA has released its long-awaited final guidance on demonstrating interchangeability of a biosimilar with its reference.

The bill seeks to prohibit brand-name drug makers from delaying the entry of generics or biosimilars by compensating competitors to keep their products off the market for a period of time in so-called pay-for-delay arrangements.

The Center for Biosimilars® recaps the top news for the week of May 6, 2019.

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

In an effort to improve price transparency, the Trump administration on Wednesday announced a final rule requiring drug manufacturers to disclose their list prices for pharmaceutical products or biologics in television ads for drugs covered by Medicare or Medicaid if the wholesale acquisition cost is $35 or more for a month’s supply. Affected drugs include adalimumab (Humira), with its wholesale acquisition cost (WAC) of $5174 per month, and etanercept (Enbrel), with its WAC of $5174 per month.

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

The idea of giving the Federal Trade Commission (FTC) more authority to cut through patent thickets blocking biosimilar competition was raised Tuesday during a hearing of the Senate Judiciary Committee about intellectual property, patent law, and the impact on drug prices.

Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.

The Congressional Budget Office this week released a report that examines the different components of what putting together a single-payer system could involve, as well as the implications. Here we highlight 2 sections of the report that are likely of interest to those following biosimilars, drug pricing and healthcare cost containment.

The Center for Biosimilars® recaps the top news for the week of April 29, 2019.

On Monday, the Seoul Central District Prosecutor’s Office in the Republic of Korea arrested an executive and another employee at biosimilar developer Samsung Bioepis for falsifying and destroying evidence and for violating audit law.

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.

“The path forward requires a sustainable, fair payment system in which drug prices reflect the value provided and reward innovations that improve outcomes,” wrote Robert M. Califf, MD, and Andy Slavitt.

Last Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Juta Pharma’s pegfilgrastim biosimilar, Grasustek.

The Center for Biosimilars® recaps the top news for the week of April 22, 2019.

The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). A representative from Samsung Bioepis has confirmed approval of the product to The Center for Biosimilars® in an email. The biosimilar is already approved in a variety of other markets under the name Benepali.

This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.