Samantha DiGrande

Under the original proposed formulary change, adult patients currently taking the reference infliximab would be switched to the biosimilar.

House Bill 4005 requires drug manufacturers to compile a report on a prescription drug if the price was $100 or more for a 1-month supply (or course of treatment lasting less than 1 month) and if the net price increased by 10% or more.

This week, the Spanish Society of Digestive Pathology (SEPD) became the most recent organization to announce an updated position statement on the use of biosimilars.

Yesterday, 9 physician groups sent a joint letter to HHS Secretary Alex Azar in which they voiced concerns about the President’s 2019 Budget and the Council of Economic Advisers’ drug plan.

Between 2013 to 2015, doctors at St. Petersburg City Hospital 15 wrote out prescriptions for 34 packages of the 500-mg dose and 31 packages of 100-mg dose, and the suspects allegedly then sold the stolen drugs for a total of around $51,000.

The biosimilar was developed by Dr Reddy’s Laboratories and first approved in India in 2007. A collaboration was announced in 2016 of Dr Reddy’s and TRPharm, under which TRPharm will register and commercialize a total of 3 biosimilar products of Dr Reddy’s in Turkey.

Coherus has announced that it sees the potential for a mid-year launch of its pegfilgrastim biosimilar.

"The pharmacist remains a very important member of the healthcare team that has the ability to explain to the patient the differences between the biologic and the biosimilar. It is the pharmacist–patient relationship that will assist the patient in making the best decisions to obtain the optimal clinical outcome," said Larry D. Wagenknecht, PharmD, FMPA, FAPhA, CEO of the Michigan Pharmacists Association.

The top 3 pharmacy benefit managers by market share will now be owned by insurers, whereas a year ago, only 1 was.

Anti–tumor necrosis factor (anti-TNF) treatment has revolutionized the management of ankylosing spondylitis (AS), but 20% to 30% of patients discontinue treatment due to failure or inadequate response to treatment. That being said, anti-TNF therapies are structurally different and have different mechanisms of action; consequently, unsuccessful treatment with 1 anti-TNF drug does not determine a patient’s potential response to another.

A recent study analyzed the long-term efficacy and safety profile of anti–tumor necrosis factor (anti-TNF) treatment in 15 patients with rhupus, a rare association defined by the coexistence of both systemic lupus erythematosus and rheumatoid arthritis (RA) in the same patient.

The trastuzumab biosimilar is priced 29.5% below the list price for the trastuzumab reference product, Herceptin.

The law, which was passed with broad bipartisan support in both the Michigan House and Senate, allows for biologics designated by the FDA as interchangeable to be substituted at pharmacies with appropriate communication of the substitution to both patients and physicians.

This week, Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label variation for its reference pegfilgrastim to now include the branded Neulasta Onpro Kit.

India-based drug manufacturer Cadila Healthcare has announced that it is planning to file a Biologics License Application (BLA) for its biosimilar pegfilgrastim with the FDA by the end of 2019. To date, no developer has been successful in gaining regulatory approval in the United States or European Union for a biosimilar of the reference pegfilgrastim.

Virginia’s House and Senate have both passed a new bill, HB1177, which prohibits PBMs from penalizing pharmacists for sharing drug pricing information with consumers.

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

A recently published editorial linked to a previous switching study for patients who had been receiving reference infliximab (Remicade) to biosimilar infliximab (Inflectra) argues that the positive results of the trial “apparently settles the case in favor of unrestricted switching of 'expensive' originator to 'cheap' biosimilar infliximab. Yet, the devil is the details."

On Thursday, JHL Biotech, a biopharmaceutical startup based in Taiwan, announced that the Bulgarian Drug Agency has approved a phase 1 clinical trial application of a proposed bevacizumab biosimilar, JHL1149.

A study published in Alimentary Pharmacology Therapeutics in December 2017 compared the outcomes, pharmacokinetics, and immunogenicity of treatment intensification strategies in patients with Crohn disease (CD) who have lost clinical response to the anti–tumor necrosis factor (anti-TNF) therapy infliximab.

Gillian Woollett, DPhil, MA, senior vice president of Avalere, recently authored an article suggesting ways that the FDA can facilitate applications and approvals for interchangeable biosimilars.

An editorial recently published in The BMJ discusses addresses 1 of the most commonly misunderstood biosimilar concepts: extrapolation.

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

At the recent European Crohn's and Colitis Organisation’s 13th Congress in Vienna, Austria, several studies investigated the efficacy of infliximab biosimilars in treating Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA).

Scott Gottlieb, MD, Commissioner of the FDA, is calling for changes to biosimilar regulation to help facilitate biosimilar approval, market entry, and competition.

The TITRATE study is designed to investigate whether intensive management of RA leads to a greater number of remissions at 12 months, in addition to examining levels of disability, quality of life and acceptability, and cost-effectiveness.

Yesterday, Eli Lilly announced that its anti–IL-17 monoclonal antibody ixekizumab (Taltz) met the primary and key secondary endpoints in the phase 3 COAST-V trial evaluating its safety and efficacy in ankylosing spondylitis.

Yesterday, President Trump released his budget proposal for the 2019 fiscal year. On the same day, the Proceedings of the National Academy of Sciences of the United States of America released a paper summarizing the NIH’s contribution of funding to new drugs approved from 2010 to 2016.

South Dakota Senate Bill 75, a biosimilar substitution bill, is expected to be signed by South Dakota’s Governor, Dennis Daugaard-R.

According to the recently released Personalized Medicines Coalition 2017 Progress report, the FDA approved a record number of 16 new personalized medicines in 2017.