Regulatory

The Center for Biosimilars® recaps the top news for the week of September 10, 2018.

Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.

The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.

“Biosimilars offer incredible health and economic opportunities in the United States, but unless substantial barriers are surmounted, these opportunities will not be fully realized,” say the report's authors.

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.

Alex Brill, CEO of Matrix Global Advisors, gave a presentation during the GRx+Biosims 2018 conference in Baltimore, Maryland that discussed the barriers to increased uptake of biosimilars in the United States, and how to address those issues.

The Center for Biosimilars® recaps the top news for the week of September 3, 2018.

The European Union already has far more approved biosimilars—45 products referencing 15 medicines—than does the United States, but as a newly released report from IQVIA states, the number of European biosimilars available today represents just a fraction of what the market is expected to contain in the coming years, raising questions about the sustainability of the market.

Contrary to experience in the United States thus far, Europe has also seen what Marc-Alexander Mahl, MD, describes as “widespread support for switching biosimilars medicines under the supervision of a healthcare provider.” In fact, regulatory bodies in the EU have spoken out stating that “In our opinion, switching patients from the originator to a biosimilar medicine or vice versa can be considered safe.”

Writing in the European Medical Journal, Anna La Noce, MD, PhD, and Marcin Ernst, MD, MBA, explain that much confusion about switching between biosimilars and reference products in the United States versus in the European Union arises from different uses of the term “interchangeability.”

While the “FDA deservers tremendous credit to enhance and expedite [biosimilars]… there is also a reluctance or hesitation to provide a full account that while the rate of approvals has picked up, the amount of biosimilars on the market [remains low]. Approval is not a synonym for competition," said Chester Davis of the Association for Accessible Medicines.

Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”

The Center for Biosimilars® recaps the top news for the week of August 27, 2018.

“This comes down to the assiduous care you must do for any clinical studies using human subjects…you don’t experiment on human beings unless you’re really going to learn something,” said Gillian R. Woollett, MA, DPhil, senior vice president of Avalere Health.

“Misleading statements...and the net impression conveyed by such materials, create undue confusion as to biosimilarity and interchangeability, inflate the risks associated with a physician-directed switch to a biosimilar, and cast doubt on the safety and efficacy of biosimilars generally,” read Pfizer's citizen petition.

Sandoz, with its filgrastim biosimilar (Zarxio) having been the first biosimilar to gain FDA approval and to launch in the US market, has had extensive experience in the biosimilars space. Carlos Sattler, MD, head of clinical development and medical affairs at Sandoz, recently spoke with The Center for Biosimilars® about both the biosimilar development process and the regulatory landscape that lies ahead.

The government is asking pharmaceutical companies to stockpile an additional 6-week supply of medicine, on top of their usual stock levels, in case normal supply routes through the European Union are disrupted.

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the organization encourages the FDA to reconsider.

The Center for Biosimilars® recaps the top news for the week of August 20, 2018.

The FDA recently sent a warning letter to Kyowa Hakko Bio, the parent company of biosimilar developer Kyowa Kirin Biologics, in reference to an inspection of manufacturing plant, Hofu-shi, in Yamaguchi, Japan.

Agalsidase beta (Fabrazyme), the first Fabry disease-specific therapy to be approved by the FDA, effectively reduces globotriaosylceramide deposits. However, the drug comes with a high price tag of approximately $300,000 per patient per year, and has been subject to shortages due to manufacturing issues.

Bio-Thera Solutions, a Chinese-based biotechnology company, says that the China National Drug Administration has accepted its Biologics License Application for a potential adalimumab biosimilar, BAT1406. This is the first proposed adalimumab biosimilar to be accepted for review in China.

Alexion’s existing C5 complement inhibitor, targeted by biosimilar developers, is used to treat patients with paroxysmal nocturnal hemoglobinuria, but the biologic must be administered every 2 weeks versus ALXN1210’s proposed 8-week intravenous dosing schedule.

The product did not earn approval for all indications of the reference Herceptin; it has been approved only for the treatment of HER2-positive gastric cancers, and not for the treatment of HER2-positive breast cancer.

“It is now time to reassess whether the current clinical development paradigm really makes sense from a scientific and economic perspective while millions of patients still have limited or, more often, no access to life-changing/life-saving [monoclonal antibodies],” writes Francois-Xavier Frapaise, MD, PhD.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency says that it is taking steps to ensure that clinical trials taking place in the country will not be adversely affected by Brexit.

The Center for Biosimilars® recaps the top news for the week of August 13, 2018.

In the FDA’s Biosimilar Action Plan, the agency indicated that it seeks to partner more closely with the Federal Trade Commission (FTC) to help remove barriers to competition that are not directly within the FDA’s control. However, in recent comments to HHS, the FTC has called on the FDA to use its own authority to foster biosimilar competition.

This week, Samsung, the parent company of Samsung BioLogics and biosimilar development company Samsung Bioepis, announced plans to invest $22 billion across business lines, including biopharmaceuticals.

The Center for Biosimilars® recaps the top 5 articles for the week of August 6, 2018.