Biosimilars

Standards for biosimilars or ‘alternative’ biologicals in India

In the highly regulated market of the EU clear and rigorous guidelines exist for approval of biosimilars. In the EU biosimilars must ensure the same quality, safety and efficacy, as any other product, along with demonstrating biosimilarity (comparability) with the reference product.

More debate over the exclusivity period for biological in the US

The debate over the length of exclusivity that biological drugs can enjoy before competition from biosimilars ensues seems set to be a long and complicated one. The latest group to join in the debate is the Office of the US Trade Representative (USTR).

Lupin and Neuclone biosimilars agreement

Indian generics manufacturer Lupin Pharmaceuticals has signed an agreement with Australian biotech firm NeuClone to access cell line technology to be used to develop biosimilar drugs targeting cancer.

Need for a global pathway for biosimilars

The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].

Enoxaparin biosimilar or not

A biosimilar of the low molecular weight heparin, enoxaparin, produced by Sandoz (Novartis’s generics division) was approved by the FDA on 23 July 2010. However, some question whether this was really a biosimilar or not.

Interchangeability or substitution of biosimilars

The interchangeability or substitution of biosimilars is a subject that differs somewhat between Europe and the US. These different approaches to biosimilars are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].

Interchangeability of biosimilars in the US

As drug manufacturers await guidance on a biosimilar approval pathway in the US, the debate goes on as to how high the bar will be set for the FDA to designate a biosimilar as interchangeable. In one critical area of the law that outlines biosimilar regulations, Congress outlines the difference between biosimilarity and interchangeability with respect to biosimilars and innovative biologicals, but the FDA has yet to define the difference.

Etanercept and quality attributes changes

Quality changes in commercially available etanercept (Enbrel) were found by Sandoz researchers over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].

Regulatory approach to biosimilar development

Legislation in Europe in 2004 created a legal pathway for approval of biosimilars and the first biosimilar, Omnitrope (somatropin) as approved by the EMA in 2006. The US is lagging behind somewhat, having only just approved a legal pathway in March 2010 and with practical guidance from the FDA still anticipated.

Quality attribute changes for rituximab

Last updated: 4 April 2013 

Sandoz researchers found quality changes in commercially available rituximab (Rituxan/Mabthera) over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities.

Questions over US biosimilars pathway in light of Teva’s BLA

Questions have arisen over whether the abbreviated pathway for approval of biosimilars in the US will ever be used. Many believe that biosimilars manufacturers will opt out of this pathway and use the normal route via a Biologic License Application (BLA). This is backed up by the fact that Teva’s biosimilar, Neutroval, was submitted to the FDA via the normal BLA route.

TNF copy biological approved in China

China-based Simcere Pharmaceutical Group (Simcere) announced on 9 May 2011 that Shanghai Celgen Bio-Pharmaceutical (Shanghai Celgen) has received approval for Qiangke – a copy biological version of etanercept – by the Chinese authorities.

Comparability for biosimilar development

How does ‘comparability’ apply to biosimilar drug development? This was the question discussed by Dr Mark McCamish and Dr Gillian Woollett [1].

Biosimilars user fees as high as brand-name fees

On 9 May 2011, the FDA proposed a user fee programme that would see drugmakers seeking approval to market biosimilars in the US initially paying fees similar to those required of originator biological drug developers.

Changes in the quality attributes of darbepoetin alfa

Quality changes over a period of time were found in commercially available darbepoetin alfa (Aranesp) by Sandoz researchers. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].

Brazil to manufacture follow-on adalimumab

The Brazilian Ministry of Health (Ministério da Saúde) announced on 5 April 2011 that it would be entering into an agreement with PharmaPraxis to manufacture a biosimilar, or follow-on version, of Abbott’s monoclonal antibody Humira (adalimumab).

Acceptable changes in quality for glycosylated biologicals

Research carried out by Sandoz into three glycosylated protein biotechnology drugs currently on the market showed quality changes over the period studied. Since all three drugs remained on the market with unchanged labels, this would indicate that the changes were accepted by the health authorities [1].

Opportunities for biosimilar development

Rising drug costs and limited healthcare budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.

Teva grabs biopharmaceutical company Cephalon

On 2 May 2011, Teva and Cephalon announced that they had unanimously approved a definitive agreement under which Teva will acquire all outstanding shares of Cephalon for US$81.50 per share in cash, or a total enterprise value of approximately US$6.8 billion.

Biobetters rather than biosimilars

‘Biobetters’, rather than biosimilars, are the next big opportunity for biopharm and contract research organisations (CROs) hoping to profit from patent expirations on biologicals, say experts.

Worldwide biosimilar development

The limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].

Generics manufacturers and biosimilars

According to a report by the Wall Street Journal on 31 January 2011, generic manufacturers are expecting biosimilars to be the next cash cow, with sums in the multibillions of dollars expected to be reaped from this market in the near future.

Pharmacodynamic response of biosimilar filgrastim

Research published online on 10 March 2011 on the pharmacodynamic response of recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim has shown that there is no difference between biosimilar and originator G-CSF.

The history of the US biosimilar regulatory pathway

The US, although it now has a legal pathway (with the approval of the Biologics Price Competition and Innovation Act [BPCI Act], which was signed into law on 23 March 2010 by President Barack Obama), does not yet have a practical pathway with guidance defined by the FDA.

Immunogenicity of biosimilar low molecular weight heparins

In a presentation by Professor JM Walenga and colleagues from the Loyola University Medical Center, Illinois,USA, 'immunogenicity issues faced by biosimilar low molecular weight heparins (LMWHs)' were discussed [1].

Comparison of US and European biosimilar regulatory pathways

The EU and the US have some differences in the way they approach biosimilars. Some of these differences were outlined in an article by Mr David Rosen and Mr Larry Lian published on 2 March 2011.

Biosimilar low molecular weight heparins in Brazil

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Agência Nacional de Vigilância Sanitária, Anvisa) is fully satisfied with their quality, efficacy and safety. Likewise for biosimilars it is necessary that the biosimilar be equally effective and safe and without contaminants in relation to the originator medicine.

Everybody jumping on the biosimilars bandwagon

According to a report by Reuters on 13 January 2011, Big Pharma is taking a major interest in the biosimilars market. During interviews with Amgen, Merck, and Biogen Idec at the JP Morgan’s 28th Annual Healthcare Conference in San Francisco, USA, biosimilars was the hot topic.

Global biosimilar market to grow to US$3.7 billion in 2015

According to a report by Datamonitor published on 23 February 2011 the global biosimilars market will grow from US$243 million in 2010 to US$3.7 billion in 2015.

Boehringer Ingelheim acquires Amgen biotech site

Boehringer Ingelheim, one of the world’s leading companies for contract development and manufacturing of biopharmaceuticals, announced on 25 March 2011 that it had formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California, USA.

Further lobbying over biosimilars

Brand-name drug companies are trying to weaken a provision of the US Patient Protection and Affordable Care Act that was designed to open up generic competition in biotechnology medicines and save billions of dollars. The industry, patients and providers are watching closely to see how the FDA will interpret the law, in documents that are expected to be released during late 2011.

Ongoing monitoring of biosimilar G-CSF (filgrastim)

Sandoz is carrying out ongoing studies to ensure the safety of its biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim G-CSF). The MONITOR-GCSF study will recruit at least 1,000 patients from a minimum of 75 centres and follow them for a maximum of six cycles of chemotherapy.

Are biosimilars an easy option for big money

With the recent JP Morgan 29th Annual Healthcare Conference 2011 in San Francisco, US came a chance for reporters to quiz all the big name firms in one easy sweep. The result reported by Reuters is that the pharma industry is poised to dive into biosimilars.

Samsung to enter biosimilars market

Everybody is jumping on the biosimilars bandwagon these days, and it seems it is not just limited to pharmaceutical companies. Contract research organisation, Quintiles, announced on 28 February 2011 that it has entered into a deal with electronics giant Samsung to provide biologicals manufacturing and biosimilar development.

Biosimilar substitution in the EU

Although many things—including regulations for licensing of biosimilars—are harmonised within the EU, the attitude towards biosimilars and their substitution within the different countries of the EU varies widely.

Spectrum to develop biosimilar monoclonal antibody

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s blood-cancer drug Rituxan (rituximab).

Biosimilars boost for South Korea

The South Korean Government has pledged to promote the biosimilars industry and plans to invest in the biosimilars industry in order to make Korea a market leader. The government will provide both financial and institutional support and is aiming to take a 22% share of the global market by 2020.

Gedeon Richter sign biosimilars’ agreement with Mochida

On 14 December 2010 Budapest-based Gedeon Richter and Tokyo-based Mochida Pharmaceutical (Mochida) announced that the two companies have entered into a comprehensive and long term license and collaboration agreement with respect to development and marketing of Richter’s biosimilar product portfolio.

Merck and Parexel form strategic alliance for biosimilars

Merck Sharp and Dohme (MSD – known in the US and Canada as Merck) and Parexel, a leading global biopharmaceutical services provider, announced on 12 January 2011 that they have entered into an alliance by which Parexel will provide a broad range of clinical development services for designated biosimilar candidates to Merck BioVentures. Merck BioVentures is a division of MSD that focuses on biosimilars.

Sandoz announces biosimilar rituximab

Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced on 10 January 2011 a phase II clinical trial for a biosimilar version of leading monoclonal antibody rituximab.