News

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

A recent meta-analysis of reference filgrastim’s (Neupogen) role in chemotherapy since its approval in 1991 shows how the definition of value has evolved over time as biosimilars for granulocyte colony-stimulating factors (G-CSF) entered the market.

The Trump administration has released its proposed budget for the fiscal year 2020, and contained within it are a variety of proposals that impact biosimilars.

Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.

The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

A survey of health plan benefit sponsors representing employers found that most are using prior authorization (PA) or step therapy to encourage the use of biosimilars, but fewer are considering mandatory switching, cost-sharing differentials, or higher cost-sharing for reference biologics for new patients, according to a report from The Pharmacy Benefit Management Institute.

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.

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.