News

China-based Clover Biopharmaceuticals recently announced that the first patient was dosed in a phase 1 trial of SCB-808, a potential etanercept (Enbrel) biosimilar.

The Center for Biosimilars® recaps the top 5 articles for the week of July 30, 2018.

The International Generic and Biosimilar Medicines Association (IGBA) recently sent a letter to HHS Secretary Alex Azar applauding the administration’s ongoing efforts to lower drug prices—as well as the FDA’s prioritization of improving the efficiency of biosimilar and interchangeable product development—and asking for a key change to the biosimilar approval process.

This week, the European Medicines Agency (EMA) announced that it will scale back and even fully suspend a number of its activities in order to cope with Brexit-related pressures, and as the possibility grows stronger that the United Kingdom and the European Union may not reach a trade agreement, some drug makers have begun to stockpile key medicines to help guard against a supply disruption.

Vizient, a healthcare performance improvement company, recently released its Drug Price Forecast Highlights biannual report that provides an estimate of the change in the cost of medicines for 2019.

This week, the district court of Massachusetts granted Celltrion’s motion for a summary judgment of non-infringement of the last patent in question in the long-running Janssen v Celltrion case.

NHS Improvement, the body that oversees the financial stability, quality, and operational performance of England’s National Health Service (NHS) trusts, reports that switching patients to biosimilars and generics of high-cost drugs led to £324 million ($424 million) in savings in the last financial year, and that it could benefit from an additional £100 million ($131 million) in savings this financial year from greater biosimilar use.

The Association for Accessible Medicines (AAM) has released the 10th edition of its annual Generic Drug Access and Savings Report that provides an outline of the savings generated by generics and biosimilars in the past year.

The World Health Organization (WHO) has produced a draft Question and Answer (Q&A) document that gives additional clarification to its 2009 guidelines for evaluating similar biotherapeutic products, particularly with respect to evaluating biosimilars of monoclonal antibodies.

The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found.

July 2018 was a banner month for biosimilars regulatory activity, both in terms of actions taken on individual products and in the wider context of the marketplace.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, recently announced that it has initiated a phase 1 clinical trial for BAT1806, a proposed tocilizumab (Actemra) biosimilar.

Pfizer announced today that the European Commission (EC) has approved its trastuzumab biosimilar, Trazimera, referencing Herceptin, for marketing. The approval makes Trazimera the fourth trastuzumab biosimilar (following Kanjinti, Ontruzant, and Herzuma) to be approved by the EC, and the first approval of an anticancer biosimilar for Pfizer.

Drug maker Mylan, which in June received FDA approval for its biosimilar pegfilgrastim, Fulphila, confirmed in an email to The Center for Biosimilars® that it has launched the biosimilar in the United States marketplace. Fulphila is the fourth biosimilar—and the first pegfilgrastim biosimilar—to become available to US patients.

While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.

Mylan, together with partner Fujifilm Kyowa Kirin Biologics, has gained a positive opinion on its adalimumab biosimilar, FKB327, from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The advisory body recommended the biosimilar for all indications of the reference Humira. If the product is granted a marketing authorization by the European Commission, Mylan plans to sell the drug under the brand name Hulio.

This month, the Maine legislature authorized a bill titled “An Act to Require Drug Manufacturers to Comply with Federal Law,” or 2017 ME S 432, which seeks to combat the misuse of Risk Evaluation and Mitigation Strategy (REMS) programs within the state.

“The common initiation in North America of infliximab as monotherapy is concerning, given the now substantial body of evidence…documenting the importance of concomitant [immunomodulators] in reducing the likelihood of secondary loss of responsiveness related to anti-infliximab antibodies," write the researchers.

This week, a federal appeals court declined to hear a petition to rehear a challenge by the Association for Accessible Medicines to a Maryland drug pricing law.

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

Biosimilar developer Sandoz announced today that the European Commission has granted a marketing authorization for Hyrimoz, an adalimumab biosimilar, for all of the indications for which the reference adalimumab, Humira, is approved.

The Center for Biosimilars® recaps the top 5 articles for the week of July 23, 2018.

A new trastuzumab (Herceptin) biosimilar has launched in India. Dr Reddy’s Laboratories, the developer of the biosimilar, indicated that the drug will be sold under the name Hervycta, and that it has been approved in India to treat HER2-postive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

“It’s one thing for us to get the biosimilar approved and go through all of that,” said Juliana M. Reed, corporate affairs global biosimilars lead for Pfizer. “That was the early conversation of the market developing. Now the market needs to be accessible.”

A little over a year after having received FDA authorization to commence its clinical program, Glenmark Pharmaceuticals has announced that its phase 1 study of GBR 310 revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between its proposed omalizumab biosimilar and the reference product, Xolair.

On the whole, the FDA’s plan, says Robert Cerwinski, JD, is “net good news for the biosimilar developers,” and should provide “tailwinds” for the industry by giving greater clarity, streamlining processes, and reducing the time and expense that biosimilar developers will need to bring their products to the marketplace.

In order to gather stakeholder input on the initiatives explained in the Biosimilar Action Plan unveiled by FDA Commissioner Scott Gottlieb, MD, last week, the FDA has announced that it will hold a public hearing on the plan on September 4, 2018.

Because tumor necrosis factor plays a role in most neurodegenerative diseases of the eye, and because etanercept has shown promise in improving recovery of injured facial nerves, authors of a recent study sought to determine whether etanercept can be used to protect retinal ganglion cells and improve visual outcomes after injury.

Yesterday, Congressman John Sarbanes, D-Maryland, introduced the Biosimilars Competition Act of 2018 in the United States House of Representatives. The bill would require biologic and biosimilar drug manufacturers to report any agreements they enter into that may keep lower-cost drugs from reaching consumers.

According to the report, Medicare Part D drugs that demonstrated the lowest annual cost increases offered higher average rebates than drugs with the highest annual cost increases.