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.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.