Reports

Spanish pharmacists publish biosimilar position statement

Home/Reports | Posted 22/02/2019

The Spanish Society of Hospital Pharmacy (Sociedad Española de Farmacia Hospitalaria, SEFH) has published a position statement on the use of biosimilars [1]. The statement expresses the position of the society on the strategies to be followed concerning the processes of selecting, evaluating and implementing these types of medicines in the healthcare setting.

WHO considers cost of cancer drugs and how to increase access

Home/Reports | Posted 11/01/2019

The increasing prices of cancer drugs is ‘impairing the capacity of healthcare systems to provide affordable, population-wide access to cancer medicines’, according to a report issued by the World Health Organization (WHO).

International promotion and education for biosimilars

Home/Reports | Posted 14/12/2018

International initiatives to promote the use of biosimilars and improve their understanding is just one of the subjects investigated by a report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) [1].

International prescribing incentives for biosimilars

Home/Reports | Posted 07/12/2018

In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) published a report that investigated, among other subjects, international prescribing incentives for biosimilars [1].

International supply side policies for biosimilars

Home/Reports | Posted 30/11/2018

A report published by the Canadian Agency for Drugs and Technologies in Health (CADTH) investigated how international supply side policies influenced the use of biosimilars [1].

International policies for interchangeability, switching and substitution of biosimilars

Home/Reports | Posted 23/11/2018

In its report into different international policies on the use of biosimilars, the Canadian Agency for Drugs and Technologies in Health (CADTH) investigated the issue of interchangeability, switching and substitution of biosimilars [1].

Canadian report into international policies for biosimilars

Home/Reports | Posted 16/11/2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report that investigates different international policies on the use of biosimilars [1].

Sustainability of biosimilars in Europe

Home/Reports | Posted 19/10/2018

Biologicals accounted for US$277 (Euros 238) billion in sales globally in 2017 and are projected to reach US$452 (Euros 388) billion by 2022. Biosimilars are making up an increasing part of this total, with the European biosimilar market being the most mature. According to Research and Markets, the biosimilar market in Europe reached US$2 billion in 2017 and is expected to exceed US$9 billion by 2023, at a compound annual growth rate (CAGR) of 29% during 2017−2023.

Addressing uncertainty in biosimilarity

Home/Reports | Posted 07/09/2018

How to address uncertainty in biosimilarity was a subject discussed by Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) during the Drug Information Association’s Biosimilars Conference 2017 [1].

Lot selection and handling for biosimilarity

Home/Reports | Posted 31/08/2018

In his presentation on Expectations and Approaches for Demonstrating Analytical Similarity, Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA) discussed lot selection and handling for biosimilarity at the DIA Biosimilars Conference 2017 [1].

Ranking and evaluation of quality attributes for biosimilarity

Home/Reports | Posted 24/08/2018

Ranking and evaluation of quality attributes for biosimilarity was a subject discussed by Dr Patrick Lynch at the US Drug Information Association’s Biosimilars Conference [1].

Analytical consideration in demonstrating similarity for biosimilars

Home/Reports | Posted 13/07/2018

According to the US Food and Drug Administration (FDA) guideline on ‘Scientific Considerations in Demonstrating Biosimilarity to a Reference Product’ [1], ‘FDA expects that first, a sponsor will extensively characterize the proposed product and the reference product with state‐of‐the‐art technology, because extensive characterization of both products serves as the foundation for a demonstration of biosimilarity’ [2].

Analytical similarity for biosimilars

Home/Reports | Posted 06/07/2018

Dr Patrick Lynch, Product Quality Reviewer at the US Food and Drug Administration (FDA), gave a presentation on demonstrating analytical similarity for biosimilars at the US Drug Information Association’s Biosimilars Conference [1].

Biosimilars development moving to Asia

Home/Reports | Posted 29/06/2018

Biosimilars manufacturing is moving to Asia with biosimilars developed in Korea contributing 43% of the global biosimilars value. This has been a quick expansion from the total share of 0% back in 2012. As outlined in Mr Per Troein’s presentation [1] on how the landscape of biosimilars development is changing, Korea has now taken over from Europe as the leading location for biosimilars manufacturing, see Figure 1.

Developing biosimilars

Home/Reports | Posted 22/06/2018

Global pharmaceutical sales have grown 6.4% over the last five years to reach US$964 billion in 2017. Although the US still accounts for the major share of drug sales other markets are growing fast. In the period 2012−2017 the pharmaceuticals market in China grew at a rate of 10.2%, making it the second biggest market by sales, accounting for US$82 billion in 2017. Brazil also experienced a huge increase in sales with growth of 12.1% during 2012−2017.

Update on the biosimilar programme in the US

Home/Reports | Posted 15/06/2018

A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

EMA studying pharmacovigilance for biologicals and biosimilars

Home/Reports | Posted 08/06/2018

New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. The European Medicines Agency (EMA) is responsible for implementing the legislation. As part of its commitments the agency released draft guidance on pharmacovigilance for biologicals in December 2015 for public consultation. This guideline has since been finalized and came into effect in August 2016.

Full or modified clinical programme for biosimilars

Home/Reports | Posted 01/06/2018

Dr Elena Wolff-Holz, from the Paul-Ehrlich-Institut and Federal Agency for Vaccines and Biomedicines, and Chair of the Biosimilar Medicines Working Party at the European Medicines Agency (EMA), gave a presentation on EMA initiatives with respect to biosimilars at the 16th Biosimilar Medicines Conference in April 2018 [1], and as part of her presentation Dr Wolff-Holz discussed cases where a full or a modified clinical programme was required for approval of biosimilars.

Alternative designs for clinical switching studies

Home/Reports | Posted 25/05/2018

A legal framework for approving biosimilars in the US was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). As part of the Food and Drug Administration’s (FDA) implementation of the BPCI Act, the agency published draft guidance on biosimilar interchangeability in January 2017 [2].

Endpoints to assess interchangeability for biosimilars

Home/Reports | Posted 18/05/2018

Potential alternative/additional endpoints to assess interchangeability were discussed by Dr Daniel F Alvarez at the US Drug Information Association’s Biosimilars Conference [1].

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