Samsung and Pfizer Expand Collaboration to Accelerate Biosimilar Production
Samsung Biologics and Pfizer have announced they are expanding their current collaboration to ramp up production of biosimilars, bringing the agreement to a value of $897 million. The announcement comes as Pfizer and another branch of Samsung both prepare for US launches of their Humira biosimilars.
340B Eligibility Associated with Reduced Biosimilar Uptake
A recently published study in Health Affairs found reduced biosimilar uptake in hospitals in the 340B program, which provides drugs at reduced cost to certain care centers. The study examined nearly 600 hospitals using claims data, the Healthcare Cost Report Information System, and a 340 participation database. 340B-eligible care centers had a biosimilar usage rate that was 66% lower than non-eligible hospitals.
Talking Immunology Biosimilars and Managed Care with Dr. Colby Evans
Biosimilars have taken an increasingly prominent role in healthcare in recent years, representing a significant point of savings for patients and managed care organizations (MCOs). However, there are still some significant challenges to increase their utilization. In a new AJMC interview, Dr. Colby Evans of Evans Dermatology Partners discusses these hurdles. The first is that patients and providers are often unwilling to make the change from more expensive reference drugs.
Study Investigates Reasons Commercial Plans Don’t Cover Some Biosimilars
Despite significant potential savings, many commercial plans do not cover biosimilars for many high-price drugs. In a recently published paper in BioDrugs, researchers found several factors underlying why payers have a low coverage preference for biosimilars over name-brand therapeutics. These include plan size, relationships with pharmacy benefit managers (PBMs), and the average yearly savings per patient.
Generics Group Wants in On UK Voluntary Scheme Negotiations
Around 40% of drugs covered by the UK’s voluntary drug revenue rebate system, the Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), are generics and biosimilars. Because of this, the British Generics Manufacturers Association (BGMA) wants in on deliberations just like the organization representing branded medications, the Association of the British Pharmaceutical Industry (ABPI).
Real-World Data Study Shows Biosimilar Rituximab for Rheumatoid Arthritis Safe and Effective
A new real-world data (RWD) study published in Rheumatology International found that patients with rheumatoid arthritis who switched from Roche’s biosimilar rituximab to Rixathon’s version of the biosimilar did not suffer any deterioration. Patients who had not taken any version of rituximab also saw similar benefits.
Exclusivity Loss Looms for Ten Key Drugs in 2023
As the year marches on, Fierce Pharma takes a look at 10 major drugs facing exclusivity losses in 2023. One of the most notable is Humira, AbbVie’s historically expensive blockbuster, which will face stiff competition from several upcoming biosimilars. Other drugs on the list include J&J’s Stellara, Sanofi’s Aubagio, and Takeda’s Vyvanse.
US Court Temporarily Shoots Down J&J’s Plan to Prevent Amgen from Releasing Stelara Biosimilar
A US District Court judge stopped J&J’s attempt to stop Amgen’s Stelara biosimilar from entering the market. The judge cited a “failure to comply,” noting that the Pfizer’s lawyers submitted documents exceeding the courts page limits. In addition, the lawyers only asked to go over the limit seven minutes ahead of submission. Pfizer may file again with documents that match the court’s specifications.
Comparing Carve-In vs Carve-Out Financing for Behavioral Health Services on Medicaid
In recent years, many state Medicaid programs have moved from carve-out financing for behavioral health (BH) services to carve-in ones. A new article in Health Affairs covers this trend, which is driven in part by growing recognition that integrating care for physical health (PH) and BH improves care outcomes and lowers premature death.
FDA Shoots Down Avastin Biosimilar Over Manufacturing Issues
The US Food and Drug Administration (FDA) has denied Biocon and Viatris’ application for their biosimilar to Avastin, a monoclonal antibody therapy for multiple cancer types. The agency cited issues related to cleaning procedures and anti-contamination protocols it noted during facility inspections in Bengalaru, India, and Johor, Malaysia, last August. The company intends to address the issues and provide the agency with a Corrective and Preventative Action (CAPA) plan.
Savings From Humira Biosimilars May Take Some Time to Kick In
With the introduction of Amgen’s Amjevita, AbbVie’s Humira loses its 2 decades of exclusivity. A slate of other Humira biosimilars are set to drop this year as well, with prices set to drop due to competition. However, the changes may be slow to take effect, as several factors are set to complicate the process of reimbursement and uptake.
First Humira Biosimilar Finally Hits Pharmacies with Two Price Points
After a 20-year monopoly on the market, AbbVie’s Humira has lost exclusivity with the entrance of Amgen’s biosimilar, Amjevita. This marks the beginning of the end of the $114 billion rheumatoid arthritis drug’s dominance, propped up by widely critiqued patent thicketing. The biosimilar will follow a dual pricing system that, at best, will be half the cost of brand name Humira.
Biosimilar Uptake on the Rise in Europe
A newly released report by IQVIA finds that the uptake of biosimilars is growing in 23 European countries. Spending on biologics grew in the past year, accounting for 35% of total drug spending. Biosimilars now directly compete with 18 original biologics in the region, with nearly 4 copycats per compound on average. However, this doesn’t mean that all patients are seeing the immediate benefits of said competition.
Eli Lilly’s Copycat Insulin Gets Interchangeability Nod from FDA
Eli Lilly has received approval for the interchangeable use of its insulin biosimilar with Sanofi’s Lantus. Patients will now be able to ask for Lilly’s biosimilar at the pharmacy as a substitution for Landus, which runs $300 dollars for a 10 mL bottle out of pocket. The move comes as public furor and legislative action builds up against pharma for the cost of insulin, a lifesaving drug that was intended to be as cheap as possible when its patent was sold decades ago.
Medicines for Europe: Improving Europe’s Health Systems with Off-Patent Medicines
Strengthening European health systems by promoting the use of off-patent medicines was the topic of several speakers during a presentation the recent Medicines for Europe Conference, held in Sitges, Barcelona, Spain from June 29th to July 1st. The speakers noted that 70% of the drugs dispensed throughout the region are off-patent, and that policies favoring these and biosimilars should be prioritized.
Biosimilar Boom May be on the Horizon, Potentially Saving Patients Billions
Biosimilars, biologic generics, hold substantial promise in expanding access to lifesaving biologics, but growth has taken a while to ramp up. With 100 biosimilars currently in the pipeline, the industry may be set up for rapid growth in the next two years. With the potential influx of new biosimilars that are significantly cheaper than their reference drugs, patients could collectively save $100 billion in the next 5 years.
Amgen’s Biosimilar of Stelara Shows Promising Preliminary Results
New preliminary results show that Amgen’s biosimilar ABP 654 is effective in reducing psoriasis symptoms. ABP 654 is a biosimilar [...]
Febrile Neutropenia Biosimilar Provides Clinical and Economic Value
An analysis published in Future Oncology found that the biosimilar pegfilgrastim (PEG) can reduce spending in patients with febrile neutropenia [...]
US Biosimilars Market – 5 Things to Look Out for in 2022
The biosimilars market in the US has ramped up significantly in the past year, amidst rising political pressure surrounding high [...]
AbbVie’s Claims of Corporate Espionage will be Investigated by US International Trade Commission
The US International Trade Commission has announced they will investigate claims that two companies planning to release a biosimilar of [...]
AJMC Study: Projected US Savings from Biosimilars, 2021-2025
In a recent study published in the American Journal of Managed Care, researchers Andrew Mulcahy, PhD, and colleagues project US [...]
ISPOR Webinar: The Future of Biosimilars
Biosimilars are poised to increase access to otherwise expensive therapies, but legal and regulatory hurdles abound. In an ISPOR webinar [...]
AMCP Partnership Forum on Biosimilars Identifies Adoption Challenges and RWE Solutions
The Academy of Managed Care Pharmacy (AMCP) Partnership Forum met in December 2020 to discuss the use of biosimilars in [...]
Part 2 of AmerisourceBergen Podcast on Insulin Biosimilars Now Available
Part two of AmerisourceBergen’s podcast series on insulin biosimilars is now available. This episode features guidance for pharmacies awaiting updated [...]
Podcast on Preparing for Insulin Biosimilar Approval Now Available
AmerisourceBergen has released part two of a podcast detailing how insulin biosimilars will affect pharmacies and patients. “In part two [...]