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.
Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes
April 24th 2025Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that legislative support and formulary changes are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.
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?
The Growing Impact of Biosimilars in IBD Care
April 23rd 2025Biosimilars are proving to be a game-changing solution in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.
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.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
Biosimilar and Biologic Use Increasing in Greek Patients With IBD
April 19th 2025A retrospective study from a single inflammatory bowel disease (IBD) center in Greece reported that from 2018 to 2022, the use of biologics increased by 28% yearly, and the proportion of patients using biosimilars grew from 33% to 67%.