Biosimilars

Acceptable changes in quality for glycosylated biologicals

Biosimilars/Research | Posted 06/05/2011

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

Biosimilars/Research | Posted 06/05/2011

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

Biosimilars/News | Posted 06/05/2011

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

Biosimilars/General | Posted 06/05/2011

‘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

Biosimilars/Research | Posted 29/04/2011

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

Biosimilars/News | Posted 29/04/2011

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

Biosimilars/Research | Posted 22/04/2011

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

Biosimilars/General | Posted 22/04/2011

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

Biosimilars/Research | Posted 22/04/2011

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

Biosimilars/Research | Posted 15/04/2011

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

Biosimilars/Research | Posted 15/04/2011

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

Biosimilars/News | Posted 08/04/2011

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

Biosimilars/General | Posted 08/04/2011

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

Biosimilars/News | Posted 08/04/2011

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

Biosimilars/News | Posted 01/04/2011

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)

Biosimilars/Research | Posted 25/03/2011

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

Biosimilars/General | Posted 25/03/2011

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

Biosimilars/News | Posted 25/03/2011

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

Biosimilars/Research | Posted 04/03/2011

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

Biosimilars/News | Posted 04/03/2011

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

Biosimilars/News | Posted 25/02/2011

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

Biosimilars/News | Posted 11/02/2011

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

Biosimilars/News | Posted 04/02/2011

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

Biosimilars/News | Posted 21/01/2011

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.

Contract manufacturing: top firms are investing

Biosimilars/News | Posted 10/12/2010

Lonza Group Ltd and ScinoPharm Taiwan Ltd, two leading manufacturers of active pharmaceutical ingredients (APIs), have struck separate deals to expand their capabilities to make biological drugs.

Market access for biopharmaceuticals and biosimilars: a case study

Biosimilars/Research | Posted 26/11/2010

Filgrastim is one of the first biopharmaceuticals for which biosimilars have entered the market. This case study illustrates the health economic challenges and the issues that arose in the R & D, registration, pricing and reimbursement of the biopharmaceutical and its biosimilars [1].

The case for health economic studies on biopharmaceuticals

Biosimilars/Research | Posted 26/11/2010

In the not too distant future, patents will expire on some major biopharmaceuticals, such as interferons, insulins and granulocyte-colony stimulating factors [1]. This is likely to lead to the market entry of a number of biosimilars. A health economic approach to market access for biopharmaceuticals and biosimilars serves to aid researchers and decision makers in pharmaceutical companies and government to identify those products in the development process that are likely to be safe, effective and cost-effective. This approach should also guide the rationale for registration, pricing and reimbursement decisions.

Biopharmaceuticals: the start of personalised medicine

Biosimilars/Research | Posted 26/11/2010

Biopharmaceuticals typically bind to their biological target, e.g. a protein linked to a disease [1]. Therefore, a biopharmaceutical is likely to be particularly efficacious in a specific subgroup of the patient population. For instance, trastuzumab is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2) protein and has been shown to be efficacious in the treatment of patients with metastatic breast cancer whose tumours over-express HER2 [2]. This has implications for the clinical development of biopharmaceuticals in that it highlights the need to select the most responsive target population, to collect information on relevant patient characteristics, and to identify suitable biomarkers for responders [3]. It could be argued that, in this respect, biopharmaceuticals involve a paradigm shift towards personalised medicine.

Health economic challenges for biosimilars

Biosimilars/Research | Posted 26/11/2010

Biopharmaceuticals represent a fast-growing segment of the pharmaceutical market, making up one third of products in the development pipeline and accounting for 9% of pharmaceutical expenditure [1]. Whereas the first generation of biopharmaceuticals tended to consist of first-in-class products addressing unmet clinical needs in small populations, e.g. bevacizumab for metastatic colorectal cancer, the current wave of products targets larger populations, e.g. insulins for type 2 diabetes mellitus [2].

Biosimilars’ hurdles in the US

Biosimilars/General | Posted 19/11/2010

Europe serves as a model for other countries looking to define their own regulatory approval criteria. However the opposing interests of biosimilar and innovative companies is resulting in delays to the development of biosimilars in the US.

The hurdles to biosimilars in Europe

Biosimilars/General | Posted 19/11/2010

The stage is set for the entrance of biosimilars into the healthcare market. Patents are near expiry on the first biopharmaceuticals and the global biosimilars market is predicted to be worth more than Euros 1.5 billion by 2015. However, development costs will be high, unlike with generic drugs, the time taken to develop biosimilars is long, and acceptance on the market is not guaranteed.

Biosimilar EPOs show the same or better quality

Biosimilars/Research | Posted 12/11/2010

Researchers have found biosimilar erythropoietin (EPO) products have the same or even better quality compared with the original branded products.

Hurdles to biosimilars in Asia

Biosimilars/General | Posted 12/11/2010

Now that a clear regulatory pathway for marketing biosimilars has been established in Europe, will Asian companies enter the global biosimilars race? Asian manufacturers face the same obstacles as western-based drugs companies, but local factors add a further twist to the tale.

Pfizer and India-based Biocon make biosimilar insulin deal

Biosimilars/News | Posted 08/11/2010

Biocon, India’s largest biotechnology company by revenue and Pfizer—the world’s biggest pharma company—announced on 18 October 2010 that they have entered into a strategic global agreement for the worldwide commercialisation of Biocon's biosimilar versions of insulin and insulin analogs (recombinant human insulin, glargine, aspart and lispro).

Hurdles to entering the biosimilars’ market

Biosimilars/General | Posted 08/11/2010

Yet more hurdles to entering the biosimilars’ market have been identified in a Reuters’ report. High development costs, complex manufacturing and legal hurdles are holding back generic drugmakers seeking to copy high cost biotech medications nearing the end of their patents.

FDA holds public hearing on biosimilars pathway

Biosimilars/News | Posted 29/10/2010

The FDA has taken further steps towards implementing guidelines on the approval pathway for biosimilars in the US by holding a public meeting on the matter.

Delays in FDA approval of biosimilar G-CSF (filgrastim)

Biosimilars/News | Posted 20/10/2010

Teva Pharmaceutical Industries announced on 30 September 2010 that the FDA has requested additional information for the Biologic License Application (BLA) for Neutroval (filgrastim), its biosimilar version of Amgen’s Neupogen (granulocyte colony-stimulating factor [G-CSF]). This action by the FDA will effectively delay any launch of the company’s first generic biotech drug in the US.

Australia approves first biosimilar filgrastim

Biosimilars/News | Posted 08/10/2010

On 26 September 2010 US-based generics manufacturer Hospira announced that it had received approval from the Therapeutic Goods Administration (Australia's regulatory agency for medical drugs and devices) for its biosimilar filgrastim product, Nivestim.

Epoetin alfa and pure red cell aplasia

Biosimilars/Research | Posted 01/10/2010

Most therapeutic proteins have the potential to induce an immune response. Cases of pure red cell aplasia (PRCA) were reported after the formulation of Eprex (epoetin alfa) was changed. It is now known that ‘the process is the product’ and the formulation cannot be changed without approval by the relevant authorities.

Approval of biosimilar epoetins: how similar are they?

Biosimilars/Research | Posted 24/09/2010

A consensus has emerged that approval of biosimilars requires both biological and clinical evidence. The ‘comparability exercise’ requires consideration of a wide range of aspects, including analytical and physico-chemical characterisation by several methods, comparative biological assays, comparative immunogenicity assessment, among others. The use of different host cells for the biosimilar product and the comparator in principle is possible.