News

Are you ready for the upcoming 2020 transition of insulins and other therapeutic proteins to US regulation as biologics and biosimilars? Find out what you need to know about the regulatory change with a new ebook from The Center for Biosimilars®.

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.

H.R. 3, The Lower Drug Costs Now Act, passed 2 committees in the House of Representatives Thursday, with a bipartisan amendment intended to boost uptake of biosimilars tucked inside.

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

A trio of employer groups has formed a new partnership to advocate for policies that address the problem of high—and growing—drug costs.

The Center for Biosimilars® recaps the top stories for the week of October 14, 2019.

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines."

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.

In a memorandum in support of its motion to dismiss the suit, AbbVie says that the complaint seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”

Representatives Paul Tonko, D-New York, and Rob Gibbs, R-Ohio, have introduced H.R. 4629, the Star Ratings for Biosimilars Act, in the House. The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees.

The less experience an oncologist has with administering rituximab, the more likely a Medicare beneficiary with non-Hodgkin lymphoma is to discontinue treatment, according to a new study. In addition, early rituximab discontinuation was associated with inferior lymphoma-specific and overall survival.

The Japanese Adverse Drug Event Report (JADER) database, a large, published database managed by the Pharmaceuticals and Medical Devices Agency for pharmacovigilance, collects spontaneous reports as a means to detect adverse events (AEs) related to drugs, and a newly published study used the JADER data to assess AEs related to the reference infliximab and to the biosimilar, CT-P13.

Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.

At this point in the legislative calendar, it is time to take a look at what may have a likely shot at passing Congress before the 2020 election season gets underway. With the contentious debate on drug pricing that has occurred during the last several months, insulin pricing is still garnering plenty of attention.

No matter which piece of a Congressional Budget Office (CBO) report or a similar one from CMS actuary that observers seize on, both documents indicate that HR 3, the Lower Drug Costs Now Act of 2019, would save federal spending and improve health, at least in the short term, and also have a dramatic impact on the prescription drug industry.

Encouraging increased competition in the biologics market with biosimilars remains the most promising mechanism to increase access. One way to foster this goal is to equip our physicians with the tools they need to make the most informed, evidence-based clinical decisions possible for their patients, including on the issue of biosimilars.

While eculizumab is being targeted by multiple biosimilar developers who are in phase 3 clinical trials with their competitive products, spending on eculizumab is reaching concerning levels; as such, it is increasingly important to clarify eculizumab’s place in the treatment paradigm for myasthenia gravis (MG).

The MAGIC Act would amend the Affordable Care Act to allow chemically synthesized insulins to be approved under abbreviated new drug applications.

While biosimilar stakeholders’ eyes have been on the recent launch of new products and on policy proposals that stand to impact these therapies, several new proposed biosimilar agents are making their way into clinical trials.

The bill prohibits these agreements between brand name and generic drug manufacturers by making them presumptively anticompetitive if the nonreference drug maker receives anything of value from the other company. The bill would make violating these provisions punishable by civil penalty.

The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment body, has issued an updated report on treatments for rheumatoid arthritis (RA) in which it says that the Janus kinase (JAK) inhibitor upadacitinib has a marginal clinical benefit over adalimumab and an "incremental cost-utility ratio falling below commonly cited thresholds.”

The International Society of Oncology Pharmacy Practitioners (ISOPP), which convened in London, United Kingdom, this week for its 18th international symposium on oncology pharmacy practice, has issued a new global position statement on biosimilars in therapeutic and supportive oncology.

The Center for Biosimilars® recaps the top stories for the week of October 7, 2019.

Major drug companies poured hundreds of millions of dollars into nonprofit patient advocacy groups last year, as a fight over federal legislation to curb rising pharmaceutical prices is underway, Bloomberg Government reports.

A new KPMG report, commissioned by generic and biosimilar trade group Medicines for Europe, identifies some of the features of drug procurement in hospitals in different countries in Europe, explains how they impact biosimilar uptake, and gives recommendations to help biosimilars play a role in the strong—and growing—need to reduce spending in health systems.

A small, yet rapidly growing segment of commercially insured US patients have drug costs of more than $250,000 each year, and this group could account for 15% of all drug expenditures in the next 5 years.

A trio of health policy experts, writing in The New England Journal of Medicine, recently analyzed 3 proposals to redesign Medicare Part D in an effort to curb the effect of rising drug prices on beneficiaries.

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.