Biosimilars

Pharmacovigilance for biologicals in The Netherlands

Biosimilars/Research | Posted 12/02/2016

Escher is an independent regulatory research platform run by Netherlands-based research enabler TI Pharma. The group recently published a paper in the journal Drug Safety on the traceability of biologicals in clinical practice and adverse drug reaction (ADR) reporting [1]. This paper concludes that in The Netherlands brand names are not routinely recorded in clinical practice and batch numbers are poorly recorded. The findings suggest that the limited traceability of brand names and batch numbers in ADR reports for biologicals may be primarily caused by the shortcomings in the recording and tracing of information in clinical practice.

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.

Kyowa to market Sandoz’s rituximab biosimilar in Japan

Biosimilars/News | Posted 12/02/2016

Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.

Adalimumab biosimilar meets primary endpoint in pharmacokinetic study

Biosimilars/Research | Posted 12/02/2016

On 21 December 2015, Baxalta, a spinoff company from Baxter International, and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced positive results from a pharmacokinetic study with their candidate adalimumab biosimilar M923.

Biosimilar etanercept offered at 47% discount in Norway

Biosimilars/General | Posted 05/02/2016

Samsung Bioepis confirmed on 1 February 2016 that it had won a contract in Norway to supply its newly approved biosimilar etanercept, Benepali, to the country.

Positive phase III results for cetuximab and infliximab copy biologicals

Biosimilars/Research | Posted 05/02/2016

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 11 January 2016 that its partner, MabTech had successfully completed phase III clinical trials in China for STI-001, a copy biological for cetuximab (Erbitux) and STI‑002, a copy biological for infliximab (Remicade). Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part phase III studies.

Lack of health insurance limits access to biologicals in India

Biosimilars/Research | Posted 05/02/2016

One example of a negative driver of the ‘similar biologics’ market in India is the lack of health insurance in the country [1].

Australian approval for infertility biosimilar Bemfola

Biosimilars/News | Posted 05/02/2016

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.

Prescribing similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 29/01/2016

Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of distinguishable names for biologicals [1].

Biosimilars applications under review by EMA – December 2015

Biosimilars/General | Posted 29/01/2016

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.

Partnerships driving similar biologics development in India

Biosimilars/Research | Posted 29/01/2016

With biosimilars grabbing an increasing share of the global biologicals market and with India providing a cheaper place to carry out research and development, more international players are partnering with Indian companies.

Filgrastim follow-on biological approved in Brazil

Biosimilars/News | Posted 29/01/2016

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).

What happened in biosimilars during 2015

Biosimilars/General | Posted 22/01/2016

The past year has once again been a busy one for the biosimilars industry [1]. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.

Domestic biologicals cost less in India

Biosimilars/Research | Posted 22/01/2016

One of the factors increasing the use of similar biologics in India is the fact that domestic biologicals cost much less than the originator brand-name biologicals [1].

Bevacizumab non-originator biological approved in Russia

Biosimilars/News | Posted 22/01/2016

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).

Barriers to biologicals competition

Biosimilars/Research | Posted 15/01/2016

As finding breakthrough small-molecule drugs becomes more difficult, drug companies are increasingly turning to ‘large molecule’ biologicals. Although biologicals represent many of the most promising new therapies for previously intractable diseases, they are extremely expensive. Moreover, the pathway for generic-type competition set up by the US Congress in 2010 is unlikely to yield significant cost savings.

EMA accepts application for etanercept biosimilar

Biosimilars/News | Posted 15/01/2016

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).

Low costs and less stringent regulatory requirements in India

Biosimilars/Research | Posted 15/01/2016

Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India in his review of ‘similar biologics’ in India, outlines some of the drivers of the ‘similar biologics’ market in India [1].

FDA approves first follow-on insulin glargine treatment

Biosimilars/News | Posted 08/01/2016

The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

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.

Pegfilgrastim biosimilar as safe and effective as Neulasta

Biosimilars/Research | Posted 08/01/2016

Sandoz, the generics division of Novartis, announced on 7 December 2015 positive results from a phase III study of its pegfilgrastim biosimilar (LA-EP2006).

Factors affecting the uptake of ‘similar biologics’ in India

Biosimilars/Research | Posted 08/01/2016

In his review of similar biologics in India, Dr Nagaraj Malipatil, a clinical pharmacologist from Bangalore, attempted to address what are the drivers and the limitations to the ‘similar biologics’ market in India [1].

Korean approval for infliximab biosimilar

Biosimilars/News | Posted 11/12/2015

Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Biosimilar adalimumab application submitted to EMA

Biosimilars/News | Posted 11/12/2015

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

Regulation and uptake of ‘similar biologics’ in India

Biosimilars/Research | Posted 11/12/2015

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India tried to address in his review of similar biologics in India [1].

Assessing the immunogenicity of monoclonal antibodies

Biosimilars/Research | Posted 04/12/2015

Safety is a major concern when it comes to biologicals (including biosimilars) and the most critical safety concern is immunogenicity. This is especially important in monoclonal antibody (mAb) biologicals, which are large molecules with complex structures and functions and which represent the largest class of biologicals [1].

Positive phase III results for adalimumab biosimilar

Biosimilars/Research | Posted 04/12/2015

US-based biologicals giant Amgen announced on 9 November 2015 that results from a phase III study of its adalimumab biosimilar (ABP 501) had ‘met the primary endpoint’.

FDA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 04/12/2015

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Infliximab price wars

Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.

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.

EMA recommends approval of etanercept biosimilar

Biosimilars/News | Posted 27/11/2015

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 November 2015 that it had recommended granting of marketing authorization for a biosimilar etanercept product (SB4).

Amgen submits biosimilar adalimumab application to FDA

Biosimilars/News | Posted 27/11/2015

Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).

AE reporting for biologicals

Biosimilars/Research | Posted 27/11/2015

Researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) sought to answer [1] examined primary suspect reports sent to the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) from US reporters for two biologicals that have lost patent exclusivity – somatropin and human insulin. The study was carried out to inform both FDA and the global drug development community about how naming of biosimilars might affect the traceability of adverse events (AEs).

Positive phase III results for etanercept biosimilar

Biosimilars/Research | Posted 27/11/2015

On 9 November 2015, biopharmaceutical specialists Coherus and Baxalta (a spin-off company from Baxter International) announced positive results from a phase III study of its etanercept biosimilar (CHS-0214).

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.

Biosimilar naming conventions around the world

Biosimilars/Research | Posted 20/11/2015

Naming conventions from around the world was one of the topics investigated in a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) [1].

Positive phase III results for Samsung Bioepis biosimilars

Biosimilars/Research | Posted 20/11/2015

Results of phase III clinical studies of candidate etanercept biosimilar SB4 infliximab biosimilar SB2 and adalimumab biosimilar SB5 have all met their primary endpoints, according to an announcement on 7 November 2015 by Samsung Bioepis (a Biogen and Samsung joint venture).

Celltrion submits rituximab biosimilar application to EMA

Biosimilars/News | Posted 20/11/2015

South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).

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.

Biosimilars and interchangeability

Biosimilars/Research | Posted 13/11/2015

In a study by researchers from the Tufts Center for the Study of Drug Development (Tufts CSDD) the question of interchangeability around the world was one of the topics investigated [1].