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.
Boosting Health Care Sustainability: The Role of Biosimilars in Latin America
November 21st 2024Biosimilars could improve access to biologic treatments and health care sustainability in Latin America, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.
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.
Eye on Pharma: EU Aflibercept Approvals; Biosimilars Canada Campaign; Celltrion Data
November 19th 2024The European Commission grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.
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.
Can Global Policies to Boost Biosimilar Adoption Work in the US?
November 17th 2024On this special episode of Not So Different honoring Global Biosimilars Week, Craig Burton, executive director of the Biosimilars Council, explores how global policies—from incentives to health equity strategies—could boost biosimilar adoption in the US.
Subcutaneous Infliximab CT-P13 Superior to Placebo as Maintenance Therapy for IBD
November 16th 2024In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the infliximab biosimilar CT-P13 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.