News

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

Biosimilars have been making substantial inroads in Europe, where their use is associated with increased patient access to treatment, particularly in nations with lower healthcare resources. Even so, biosimilars may be unfamiliar to stakeholders, and prescribers, pharmacists, and patients have lingering concerns about these products.

Two senators from either side of the aisle introduced a bill this week that is aimed squarely at the patent strategies that are used to block biosimilars from coming to market.

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

The Center for Biosimilars® recaps the top news for the week of March 4, 2019.

The Medicare Payment Advisory Commission (MedPAC) begins its 2-day March meeting Thursday, and the first item on the agenda is a discussion about reference pricing and binding arbitration for Part B drugs in order to improve price competition and value.

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

The launch of biosimilar adalimumab products in the European Union in October 2018 was an important moment for health systems in serious need of cost savings on one of their top drugs for spending: Humira. Now, early data show that adalimumab biosimilars are off to a strong start in the EU market.

A few weeks after the United States Supreme Court rebuffed Maryland in its attempt to regulate drug prices, legislative committees are meeting Wednesday on a drug price transparency bill, as well as a bill to create a commission to review prices and set ceilings on insurers, pharmacies and hospitals.

News that FDA Commissioner Scott Gottlieb, MD, will step down from his position in 1 month’s time took stakeholders by surprise on Tuesday and raises questions about how the agency will approach biosimilars when it comes under new leadership. While Gottlieb’s departure has garnered the most attention, it is not the only recent FDA shake-up that could have an impact on the agency’s approach to biosimilars; Leah Christl, PhD, previously the director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, left the FDA in February 2019.

FDA Commissioner Scott Gottlieb, MD, will be stepping down from his post in 1 month.

A Kaiser Health News (KHN) analysis found that about one-half of the patient advocacy groups appearing in national ads opposing a Trump administration proposal to change how Medicare Part D covers drugs in protected classes have received pharmaceutical industry funding.

The FDA has approved a subcutaneously administered version of the brand-name trastuzumab, Herceptin. The new formulation, trastuzumab and hyaluronidase-oysk, is a combination of the anticancer agent trastuzumab and an endoglycosidase that allows for the administration of higher volumes and enhanced absorption, and it has been approved under the name Herceptin Hylecta.

Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.

Napp Pharmaceuticals has announced the UK launch of Pelmeg, a biosimilar pegfilgrastim developed by Cinfa Biotech and subsequently acquired by Mundipharma.

In February, the FDA issued a drug safety communication on tofacitinib (Xeljanz), an oral, small-molecule Janus kinase (JAK) inhibitor. According to the FDA communication, a clinical trial in patients with rheumatoid arthritis who were taking an as-yet unapproved 10-mg dose of tofacitinib twice each day found an increased risk of blood clots and death.

Mylan revealed in its recent fourth quarter 2018 earnings call that it had an initial advisory meeting with the FDA regarding a proposed biosimilar onabotulinumtoxinA, referencing the brand-name Botox.

The industry group for pharmacy benefit managers (PBMs) launched a public relations blitz in the wake of scrutiny regarding their role in prescription drug prices.

Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.

Apobiologix, a division of Apotex, launched its pegfilgrastim biosimilar, Lapelga, in Canada this week. The company’s product, which gained Health Canada’s authorization in 2018, was the first biosimilar pegfilgrastim to be approved in any highly regulated territory.

The Center for Biosimilars® recaps the top news for the week of February 25, 2019.

A California legislator wants to make the state the first to bar “pay-for-delay” tactics used by drug companies to prevent competition, targeting both generics and biosimilars, in a move that would create the first piece of state law about this issue.

As the United Kingdom continues to move toward its exit from the European Union without an agreed-upon deal, the UK National Institute for Biological Standards and Control has issued new guidance for manufacturers of biologics in preparation for a no-deal Brexit, and the European Medicines Agency issued a new communication to drug makers seeking Brexit-related Type 1 variations to their marketing authorizations.

February 2019 was a busy month for biosimilars on the policy front, with pharmaceutical executives called to testify before law makers and industry attempting to navigate a raft of proposed Trump administration policies aimed at reducing the cost of drugs.

On this Rare Disease Day, learn more about how biosimilars are poised to help treat patients with rare diseases.

Researchers say they validated whole blood expression of a gene involved in inflammatory response as an accurate biomarker predicting response to anti–tumor necrosis factor (TNF) for endoscopic remission in patients with Crohn disease (CD) and ulcerative colitis (UC), both types of inflammatory bowel disease (IBD) in a finding that could assist in deciding whether biologic-naïve patients should receive anti-TNF therapy.

Regulators in China have approved the country’s first ever biosimilar, a rituximab product referencing Rituxan. The product, HLX01, was developed by Henlius and will be primarily used in the treatment of non-Hodgkin lymphoma. Regulatory requirements that were applied in the analysis of the drug, say investigators who took part in its development, will set a precedent for analytical similarity assessments of biosimilars in China going forward.

This week, US Magistrate Judge Richard Lloret directed Boehringer Ingelheim to disclose its launch plans for its biosimilar adalimumab, Cyltezo, as part of a long-running patent dispute with AbbVie, maker of the reference adalimumab, Humira.

A recent study aimed to evaluate patients’ and nurses’ preferences for the autoinjector for a biosimilar adalimumab marketed as Imraldi in the European Union versus autoinjectors of reference adalimumab or reference etanercept.

In today’s second full committee hearing on drug pricing held before the US Senate Committee on Finance, executives representing 7 drug makers provided testimony on the high prices of their products.