Reports

What can the US learn from the European biosimilars market?

Home/Reports | Posted 12/02/2021

In a report produced for the Biosimilars Council, which is a division of the Association for Accessible Medicines (AAM), authors discuss the lessons that the US might learn from the European experience with biosimilars [1].

FDA publishes report on areas of regulatory focus for 2021

Home/Reports | Posted 12/02/2021

The US Food and Drug Administration (FDA) announced on 11 January 2021 that it had published its Focus Areas of Regulatory Science (FARS) report. One of the areas of focus identified by the report is increasing access to generic alternatives for complex drugs.

FDA includes generics of complex drugs in regulatory focus

Home/Reports | Posted 05/02/2021

One of the areas of focus identified in a new report issued by the US Food and Drug Administration (FDA) is increasing access to generic alternatives for complex drugs.

Biosimilars policy considerations in the US

Home/Reports | Posted 05/02/2021

When it comes to policy considerations, the new product entrants always face considerable challenges. Recent legislation and regulation intend to level the playing field and create fair competition for biosimilars to allow for their growth. However, some have been designed to favour biosimilars. In light of this, the report highlights the Prescription Drug Pricing Reduction Act of 2019 (currently stalled) that will allow providers to get higher levels of reimbursement for biosimilars than for reference products.

US biosimilars reimbursement: Medicare and 340B

Home/Reports | Posted 29/01/2021

2020 sees the publication of the seventh edition of Biosimilars Trend Report. This describes the landscape for biosimilars in the US in 2020, with an update on the Medicare and 340B programme.

Key considerations for payers, employers and patients in the US biosimilars market

Home/Reports | Posted 22/01/2021

While financial savings are important for driving biosimilar uptake, they are not the only consideration for payers and providers. Other factors include manufacturer reputation for producing high-quality products, reliably supplying these products, and understanding provider and payer clinical, economic and operational needs and decision-making drivers.

Key considerations for providers in the US biosimilars market

Home/Reports | Posted 08/01/2021

When it comes to the adoption of biosimilars, healthcare professionals (physicians, physician assistants, nurse practitioners and pharmacists) are key, noted in the Biosimilars 2020 Trend Report. They must have confidence in biosimilar approvals and support their uptake through prescribing. Providers need to have operational processes in place to allow for the use of biosimilars and must have assurance that these products are covered by payers. Most importantly, they have a key role in educating patients and ensuring the safe everyday use of biosimilars.

US market trends in oncology/nephrology supportive care and inflammation biosimilars

Home/Reports | Posted 11/12/2020

This article provides an overview of the biosimilars currently available in oncology supportive care, nephrology/oncology supportive care and inflammation in the US.

US biosimilars trends in oncology therapeutics

Home/Reports | Posted 04/12/2020

The Biosimilars Trend Report published in 2020 describes the landscape for biosimilars in the US. The current biosimilars available for oncology therapeutics are trastuzumab, bevacizumab and rituximab. Overall, biologicals make up approximately half of all oncology products and they are expensive due to higher development and production costs. Biosimilars offer an opportunity to reduce the cost of oncology treatments. As of July 2020, 12 oncology biosimilars were available in the US.

The US biosimilars market in 2020

Home/Reports | Posted 27/11/2020

The 2020 Biosimilars Trend Report opens by stating that the US marketplace is ready to welcome many new biosimilars in 2020 and the years to come [1]. Recent US regulations have levelled the playing field for biosimilars and reference products. For example, the Centers for Medicare and Medicaid Services (CMS) has made changes to the US reimbursement system which has established a Healthcare Common Procedure Coding System (HCPCS) and payment rates for biosimilars. Such changes are hoped to foster competition and create a more sustainable marketplace.