NeuClone Developing Biosimilars of PD-1 Inhibitors
The Australia-based biosimilar company hopes to compete with blockbuster programmed death-1 (PD-1) inhibitor franchises owned by Merck and Bristol Myers Squibb.
Biosimilar Developers and the Battle Against COVID-19
A look at efforts biosimilar manufacturers are taking to develop treatments for coronavirus disease 2019 (COVID-19).
Biosimilar Rheumatology Roundup: August 2020
The month of August was replete with clinical trial news and biosimilar launches for the treatment of rheumatic conditions.
Investigators Eye Gaps in Biosimilar Assessment Reports
Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.
Biocon, Mylan Launch Semglee and Seek Biosimilar, Interchangeable Status
For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to clinch the marketing aspect.
The Pandemic's Multilevel Effect on Patient Access
Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.
Cadila Launches Fourth Biosimilar in 2 Months
With the launch of an adalimumab, Cadila hopes to get a piece of the worldwide biosimilar market for antirheumatic treatments.
Midwest Business Group on Health Issues Call to Action on Biosimilars
To help employers achieve biosimilar savings, the Midwest Business Group on Health has created a 13-step action plan.
The Top 5 Biosimilar Articles for the Week of August 24
Here are the top 5 biosimilar articles for the week of August 24, 2020.
Short Course on Biosimilar Supportive Care During the Pandemic
Julianna Merten, PharmD, BCPS, BCOP, of Mayo Clinic provides an overview of growth factor biosimilars for pharmacists amid the pandemic.
Updated "User's Guide" Published for Anti-TNFs in IBD
Two decades of using anti–tumor necrosis factor (TNF) drugs in inflammatory bowel disease (IBD) have answered some questions and left others unanswered.
Dan Leonard Takes Helm of Association for Accessible Medicines
The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.
Mylan, Lupin Launch Etanercept Biosimilar in Germany
The launch marks the first European market entry for Nepexto.
Expert Opinion Roundup: New Insulin and Biosimilar Regulation
Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.
Symposium: Treating Inflammatory Conditions With Biosimilars
A September 29, 2020, symposium with Sonia T. Oskouei, PharmD, BCMAS, DPLA, of Cardinal Health will explore how to incorporate biosimilars into the treatment of inflammatory conditions.
Celltrion to Begin Phase 1 Trial for Denosumab Biosimilar
Celltrion Healthcare said it will begin testing its denosumab (Prolia) biosimilar in a phase 1 clinical trial in September.
British Columbia Moves Into Third Phase of Mandatory Switching
The statistics show that for the Rocky Mountain province, biosimilar savings are pouring into the health care system and allowing for significantly greater access.
Biogen: Anti-TNF Biosimilars Are Underutilized
Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.
BeiGene, Bio-Thera Carve Out Bevacizumab Market
From China to Taiwan, BeiGene and Bio-Thera Solutions hope to capture a large share of the bevacizumab biosimilar market.
Formycon, Bioeq Enroll First Patient in Phase 3 Aflibercept Study
Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.
Celltrion, Intract Pharma Strive for World's First Oral Infliximab
Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.
Samsung Biologics' Mega Plant Is Officially Underway
Samsung Biologics said it expects to invest over $2 billion in its new manufacturing plant and bio complex, for which construction will begin later this year.
Amgen, Coherus Pegfilgrastims Lose Formulary Placement
Express Scripts, the country's largest pharmacy benefit manager, has reshuffled its preferred formulary list for 2021, giving preference to fewer pegfilgrastim products than in 2020.
The Top 5 Biosimilar Articles for the Week of August 17
Here are the top 5 biosimilar articles for the week of August 17, 2020.
FDA Reassures on Biosimilar Progress as COVID-19 Applications Pile Up
The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.
Samsung Bioepis' Bevacizumab Is Cleared for Launch in Europe
Samsung Bioepis' latest approval gives it 5 biosimilar approvals in the European marketplace.
Sandoz Canada Launches Ziextenzo, Riximyo
After receiving regulatory approval in June, Sandoz launched 2 of its biosimilars on the Canadian market.
Fauci Discusses Experimental COVID-19 Drugs and School Openings
Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.
US May Need to Look to Germany to Reform Drug Pricing
US administrative and legislative efforts are moving the United States and Germany more into alignment on drug cost management philosophy, according to a review.
PATRO Study Supports Omnitrope for Growth Deficiency
A postmarketing surveillance study of Omnitrope in pediatric patients with growth hormone deficiency sheds new light on how this agent performs relative to its reference product.