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.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas
January 16th 2025Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.