Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.
Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.
5. Amgen's Eculizumab Biosimilar, ABP 959, Shows PK, PD Bioequivalence to Soliris
Amgen is developing ABP 959, a biosimilar of eculizumab (Alexion’s Soliris), and at the 24th Congress of the European Hematology Association, held from June 13-16, 2019, in Amsterdam, the Netherlands, researchers reported on findings from a phase 1 trial of the proposed product. Alexion’s Soliris, a complement inhibitor, is among the highest-cost biologics on the market, carrying a list price of approximately $500,000 per patient per year. Eculizumab is used to treat generalized myasthenia gravis, paroxysmal nocturnal hemoglobinuria, and atypical hemolytic uremic syndrome, all rare and ultra-rare diseases.
4. What's New in Medicare Part B for Biosimilars
The current administration in Washington, DC, is one of the most active when it comes to policy and regulation that affects biosimilars, said a presenter who recapped recent changes for the attendees at the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia.
Molly Burich, MS, of Boehringer Ingelheim Pharmaceuticals, Inc, recapped 2018 changes to reimbursement for biosimilars by CMS in Part B. While not every rule or regulation is specific to biosimilars, almost everything the government does has an impact, she said.
3. At the J.P. Morgan Healthcare Conference, Coherus Outlines "Branded Approach" to Biosimilars
During the second day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10, 2019, in San Francisco, California, Dennis M. Lanfear, president and CEO of Coherus BioSciences, presented an overview of what he called his company’s “branded approach” to selling its then newly launched biosimilar pegfilgrastim, Udenyca.
2. Looking to the Future, Biosimilar Pioneer Celltrion Is Banking on Biobetters
Improvements in biosimilars—ones that may give them an advantage, such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars, according to Sang Joon Lee, PhD, senior executive vice president of Celltrion, who gave a keynote speech at the FT Global Pharmaceutical and Biotechnology Conference in London, United Kingdom, on November 12, 2019.
During the first day of the 37th Annual J.P. Morgan Healthcare Conference, held January 7-10, 2019, in San Francisco, California, 2 major biosimilar developers gave a look at their strategies for the year and beyond. Pfizer’s CEO, Albert Bourla, DVM, PhD, and president of worldwide research and development Mikael Dolsten, MD, PhD, discussed Pfizer’s outlook for the coming years. Kare Schultz, CEO of Teva, discussed how his company was on track with its approximately $3.2 billion debt restructuring plan.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access
April 28th 2025Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market
April 25th 2025Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas.