Reports

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.

Biosimilars trend report 2020

Home/Reports | Posted 20/11/2020

The seventh edition of the Biosimilars Trend Report 2020 has been published. This 2020 report was developed based on input from members of the healthcare community in the US [1].

Smart healthcare spending and the Falsified Medicines Directive in Europe

Home/Reports | Posted 06/11/2020

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued a white paper on ‘Strengthening health systems through smart spending’ and a ‘Benefits beyond the EU Falsified Medicines Directive - The hospital setting’ report.

Challenges faced by biosimilar orphan drugs in European health systems

Home/Reports | Posted 30/10/2020

As treatments for rare diseases become a greater healthcare priority, the contribution of biosimilars as a means of reducing costs and increasing patient access will become more important for the long-term sustainability of health systems [1]. While the current impact of non-orphan biosimilars suggests this contribution could be significant, uptake of biosimilars across Europe remains variable and there is a risk that sustainable competitive markets are not yet established. A recent review of biosimilar policies in Europe found that key principles for a sustainable biosimilar market include supporting innovation, physician prescribing freedom, and allowing for multiple suppliers [2].

Commercialization challenges for biosimilar orphan drugs

Home/Reports | Posted 23/10/2020

Companies seeking to commercialize orphan drug biosimilars are likely to face challenges associated with limited potential market size, uncertainty regarding expanding patient access and loyalty to the reference product.

Clinical development challenges faced by orphan drug biosimilar developers

Home/Reports | Posted 16/10/2020

Biosimilar development is more costly and requires greater effort to conduct analytical and clinical testing than generic drug development. These challenges can be amplified when developing a biosimilar of an orphan drug.

The landscape for orphan drugs in Europe

Home/Reports | Posted 09/10/2020

The discovery and development of medical products for the prevention, diagnosis and treatment of rare diseases has been a public health priority in Europe for several decades [1]. Rare diseases in this context are defined as chronically debilitating or life-threatening conditions that affect fewer than five in 10,000 people within a given community, or diseases which are unlikely to generate a sufficient return on investment for developers without incentives.

Generics and biosimilars can save Ireland Euros 1 billion in five years

Home/Reports | Posted 09/10/2020

Medicines for Ireland (MFI) launched their ‘Reductions in the Cost of Medicines – Ireland’s Patients First 2020–2022’ report on 29 September 2020. This report outlines how additional savings of up to Euros 1 billion in the next five years can be achieved through increased use of generics and biosimilars.