Biosimilars/General

Celltrion to use cloud-based technology for its biosimilars trials

Biosimilars/General | Posted 19/02/2016

On 20January 2016, Korea-based biopharmaceutical company Celltrion announced that it had adopted Medidata’s Clinical Cloud to provide scalable technology for its biosimilars development programmes. The technologies include electronic data capture and management (Medidata Rave), medical coding (Medidata Coder) and randomization and trial supply management (Medidata Balance).

Biologicals patent expiries

Biosimilars/General | Posted 13/11/2015

Biosimilars are now a reality. The European Medicines Agency (EMA) approved its first biosimilar back in 2006 [1] and, with the increasing price of new biologicals and continuing pressure on healthcare budgets, biosimilars are expected to make up an increasing share of the biologicals market.

Launch of partnership for biosimilars education and access

Biosimilars/General | Posted 12/02/2016

The Biosimilars Forum announced on 1 February 2016 the launch of a new biosimilars education initiative. The ‘Partnership for Biosimilars Education and Access’ will focus on raising awareness and encouraging access to biosimilars in the US.

Inflectra PBS listing expected to deliver savings in Australia

Biosimilars/General | Posted 08/01/2016

The infliximab biosimilar Inflectra was approved for listing in Australia’s Pharmaceutical Benefits Scheme (PBS) on 1 December 2015. This is a decision that ‘will deliver immediate savings’ to the Australian Government, according to the Generic and Biosimilar Medicines Association (GBMA), a group that represents generic and biosimilar medicine suppliers in Australia.

Outcry at new US biosimilars reimbursement policy

Biosimilars/General | Posted 04/12/2015

A newly announced US Centers for Medicare and Medicaid Services (CMS) rule that gathers together all biosimilars of a single reference product under just one code has been widely criticized by drugmakers. Drugmakers warn that the rule on Medicare physician payment would reduce incentives for developing biosimilars, reduce patient access and create safety issues due to the inability to differentiate between biosimilars and reference products.

Biosimilar naming in the US, the debate continues

Biosimilars/General | Posted 20/11/2015

The United States Pharmacopeial Convention (USP) has called on the US Food and Drug Administration (FDA) to reconsider its draft guidance Nonproprietary Naming of Biological Products: Guidance for Industry.

Generics group established first voice for biosimilars in Canada

Biosimilars/General | Posted 27/04/2015

The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 2015 that it had set up a new CGPA Biosimilars Board, with Mr Michel Robidoux, President and General Manager of Sandoz Canada, as its inaugural Chair.

Australia’s DoH seeks feedback on biosimilars awareness project

Biosimilars/General | Posted 16/10/2015

Australia’s Department of Health (DoH) wants to improve awareness and confidence in biosimilars in the community and among healthcare professionals, including pharmacists and prescribers. To do this the DoH has developed an implementation framework, for which it is seeking feedback.

Call for compulsory license for biosimilar trastuzumab emtansine

Biosimilars/General | Posted 23/10/2015

A pressure group, which includes both patients and doctors, has called for the UK Government to overturn patents on Roche’s breast cancer treatment Kadcyla (trastuzumab emtansine).

European paediatricians advocate biosimilar trials in children with IBD

Biosimilars/General | Posted 09/10/2015

Paediatricians from Europe are concerned about the extrapolation of the limited amount of available clinical data from adults with rheumatologic diseases to children with inflammatory bowel disease (IBD) [1].

Dutch medicines agency aims to clarify biosimilars confusion

Biosimilars/General | Posted 25/09/2015

The Dutch Medicines Evaluation Board (MEB) has further clarified its position on biosimilars since its last update in March 2015. The MEB had previously raised concerns among patient groups and professional organizations with the announcement that biosimilars had no relevant differences to originators.

Comments on FDA’s guidance on naming biologicals

Biosimilars/General | Posted 11/09/2015

The US Food and Drug Administration (FDA) issued a draft guidance on the non-proprietary naming of biological products on 27 August 2015 [1], but not everyone is happy with the proposals made by the agency.

Australian approval for infliximab biosimilar

Biosimilars/General | Posted 21/08/2015

South Korean biotechnology company Celltrion announced on 10 August 2015 that its partner Hospira had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for the infliximab biosimilar Inflectra.

ACR position statement on biosimilars addresses naming and substitution

Biosimilars/General | Posted 31/07/2015

The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability, substitution, naming and post-marketing surveillance of biosimilars.

Polish firm gets EIB loan for biosimilars development

Biosimilars/General | Posted 03/07/2015

The European Investment Bank (EIB) is lending Euros 45 million (around Zloty 185 million) to the largest Polish manufacturer of pharmaceuticals, Polpharma, for its research into, and development of, biosimilars.

Concerns raised over Australian decision to substitute biosimilars

Biosimilars/General | Posted 26/06/2015

In May 2015, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that originator biologicals could be substituted by biosimilars by physicians and pharmacists [1]. However, pharmacy companies, as well as physician and patient groups have reacted with concern over the decision.

Australia’s PBAC recommends substitution of biosimilars

Biosimilars/General | Posted 19/06/2015

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that biosimilars are suitable for substitution at the pharmacy level.

Biosimilar infliximab offered to French hospitals at 45% discount

Biosimilars/General | Posted 31/07/2015

A major French hospital group has chosen biosimilar infliximab to treat its patients with rheumatoid arthritis, Crohn’s disease and psoriasis, after major discounts on the drug were offered to the group.

Spanish Society of Rheumatology issues position statement on biosimilars

Biosimilars/General | Posted 12/06/2015

The Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability and traceability of biosimilars.

GPhA launches Biosimilars Council

Biosimilars/General | Posted 29/05/2015

As part of ongoing efforts to educate and expand access to biosimilars, industry group, the US Generic Pharmaceutical Association (GPhA), has launched its Biosimilars Council, a division of GPhA.

Biosimilars Forum launched

Biosimilars/General | Posted 08/05/2015

A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars in the form of the Biosimilars Forum.

Australian guide to biosimilars

Biosimilars/General | Posted 04/05/2015

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, clinicians, pharmacists, politicians and policymakers.

WHO receives positive feedback on BQ for biologicals

Biosimilars/General | Posted 27/04/2015

According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances, almost half of comments on its proposed biological qualifier (BQ) for naming biologicals were positive.

Arguments for same INN for biosimilars presented at WHO meeting

Biosimilars/General | Posted 17/04/2015

The World Health Organization recently held its 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals, including biosimilars was once again discussed.

Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators

Biosimilars/General | Posted 10/04/2015

The Dutch Medicines Evaluation Board (MEB) has updated its position on biosimilars, stating that ‘biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned’.

Rheumatologists want to evaluate long-term safety of biosimilars

Biosimilars/General | Posted 27/03/2015

One of the biggest challenges for biosimilar companies is to convince physicians to use biosimilars instead of their well-known biological counterparts. One of the issues that physicians see as a concern is the long-term safety of biosimilars, a concern that is thought could slow down the adoption of biosimilars. This issue has even prompted certain organizations to embark on programmes that seek to provide definitive evidence on the issue.

Huge discount on biosimilar infliximab in Norway

Biosimilars/General | Posted 13/03/2015

Norway’s price regulator has been offered a discount of 72% for biosimilar infliximab in the country’s latest tender for drugs.

Norwegian study hopes to increase biosimilars uptake in Europe

Biosimilars/General | Posted 06/12/2013

Despite the fact that many countries within Europe are tightening its health budget, the uptake of lower-cost biosimilars is still relatively low in Europe.

EuropaBio calls for distinguishable names for biosimilars despite potential of big savings

Biosimilars/General | Posted 28/11/2014

On 6 November 2014, the European Association for Bioindustries (EuropaBio) published a new guide and a new position paper on biosimilars in Europe. EuropaBio expects these two documents to contribute to the policy debate on key issues regarding biosimilars among European and national regulators, policymakers, physicians, other healthcare providers, and patients.

More discussion over WHO biological qualifier

Biosimilars/General | Posted 21/11/2014

The World Health Organization recently held its 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals including biosimilars was once again discussed.

ABPI issues updated position paper on biosimilars

Biosimilars/General | Posted 02/06/2014

On 14 May 2014, the association that represents innovative research-based biopharmaceutical companies in the UK, the Association of the British Pharmaceutical Industry (ABPI), issued the third edition of its position paper on biosimilars.

IAPO releases toolkit for biologicals and biosimilars

Biosimilars/General | Posted 03/10/2014

The International Alliance of Patients’ Organizations (IAPO), which comprises over 200 patient groups and represents the interests of patients worldwide, has published an Information and Advocacy Toolkit on Biological and Biosimilar Medicines for Patients’ Organizations. The Toolkit, published in November 2013, provides up-to-date, evidence-based information on the science, technology and regulatory information relevant to biologicals and biosimilars.

Call for action on labelling of biosimilars

Biosimilars/General | Posted 26/09/2014

European trade association, the European Association for Bioindustry (EuropaBio) has called on the European Medicines Agency (EMA) to define specific guidance on the labelling of biosimilars.

Biosimilars applications under review by EMA – August 2014

Biosimilars/General | Posted 26/09/2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

FDA debuts purple book for biologicals and interchangeable biosimilars

Biosimilars/General | Posted 12/09/2014

On 9 September 2014, the US Food and Drug Administration (FDA) announced the publication of its first-ever edition of the ‘Purple Book’, a new set of lists of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic equivalents.

US senators call for guidance on biosimilars

Biosimilars/General | Posted 05/09/2014

A growing number of US senators are calling on the country’s Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) to release guidance on key scientific policy questions related to biosimilars.

WHO investigates use of a biological qualifier for biosimilars

Biosimilars/General | Posted 11/04/2014

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.

Physicians believe biosimilars should have different names

Biosimilars/General | Posted 29/08/2014

In the ongoing debate over how to name biosimilars, US physicians have now added their opinion to the discussion.

WHO proposal offers clarity for biosimilar nomenclature

Biosimilars/General | Posted 14/08/2014

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.

32 organizations agree biosimilars should have same names

Biosimilars/General | Posted 04/07/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals and biosimilars to have the same International Nonproprietary Name (INN).