Biosimilars

Also noted on biosimilars: 11 May 2012

Sandoz testimony at FDA hearing on biosimilars will emphasise need for consistent regulatory standards across all biologicals
Sandoz announced on 9 May 2012 that Dr Mark McCamish, Head of Global Biopharmaceutical Development, would present on behalf of the Novartis Group of companies (Novartis) at the 11 May 2012 FDA public hearing on draft guidances for biosimilars.

The message he will convey will focus on the need for a single science-based regulatory standard that FDA should apply across all biologicals, irrespective of the business model of the sponsor. As well as a single standard, Dr McCamish will address the points that biosimilar clinical studies should be only confirmatory and the fact that interchangeability is critical to maximising access to affordable biosimilars for US patients.

Source: Sandoz

Bayer opposes sorafenib compulsory licence in India

German pharma giant Bayer told Reuters on 5 May 2012 it had challenged a decision by the Indian Government, which allows India-based generics firm Natco Pharma to sell a generic version of Bayer’s liver and kidney cancer drug Nexavar (sorafenib) in India, before its patent expires in 2020.

Abbott asks FDA to block adalimumab biosimilar

Abbott Laboratories (Abbott) submitted a 30-page citizen petition to FDA on 2 April 2012 asking the agency to reject any biosimilar for its rheumatoid arthritis drug Humira (adalimumab). Abbott says that FDA would be forced to use trade secrets included in Humira’s Biologics License Application (BLA) to approve biosimilars. Abbott is therefore requesting that FDA refuses to review any biosimilar biological whose BLA was submitted before the Biologic Price Competition and Innovation (BPCI) Act of 2009 came into effect on 23 March 2010.

Bioavailability comparison of brand-name and generic acetylcysteine in China

A study comparing brand-name and generic acetylcysteine in China by Liu et al has shown that the generics test formulation was bioequivalent to the originator drug [1].

EMA reviews its first biosimilar monoclonal antibody

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012 the agency will be reviewing a new application for a biosimilar version of infliximab.

Study of biosimilar enoxaparins in Brazil

Analysis of biosimilar enoxaparins available for clinical use in Brazil by the Laboratório de Tecido Conjuntivo in Brazil have shown that the biosimilar preparations of enoxaprain are similar to the originator drug [1].

Novartis versus the Indian patent system

The Indian patent system is once again under scrutiny as a final decision in the case of Novartis versus the Indian patent system is eagerly awaited by originator biologicals and biosimilars manufacturers alike. However, any decision on the case has been delayed until 10 July 2012.

Samsung to launch biosimilars by 2015 at half the current prices

South Korean electronics giant Samsung told the Financial Times that it plans to launch biosimilars by 2015 at half the prices that patients in Europe and the US currently pay.

Biocon opens new research centre

Indian biosimilars major Biocon, announced on 5 April 2012 the opening of a new state-of-the-art Integrated Research and Development Centre in Bangalore, India.

EMA publishes procedural advice for biosimilars

On 11 April 2012, EMA published a new document on regulatory procedural advice for biosimilars.

Biosimilars dilemma over reference products

Global manufacturers of biosimilars have a dilemma on their hands concerning reference products. What to do to reduce the burden of data required in different countries and regions of the world to get their biosimilars onto the market?

Also noted on biosimilars: 13 April 2012

Palivizumab biosimilar successfully produced in plants
Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 10 April 2012 that it had successfully used its iBioLaunch technology to produce biosimilar palivizumab in non-transgenic green plants.

This is the second monoclonal antibody that the company has successfully produced. Back in October 2011 the company announced the successful use of its technology to produce rituximab.

Related article

Rituximab biosimilar successfully produced in plants

Source: iBio

Current and future issues surrounding biosimilars

Biological medicines are already becoming an increasingly important part of health care. With patent expiries on originator biological products, biosimilars are also increasingly become a part of this future [1]. In fact, by 2020 twelve of the top-selling biologicals will have lost patent protection, opening up an estimated US$24 billion in EU sales and US$30 billion in US sales [2].

BIO and GPhA support biosimilar and generic user fees

Both the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) have expressed their support of user fees for biosimilars and generics.

Also noted on biosimilars: 6 April 2012

Amgen and AstraZeneca make monoclonal antibody deal
Biotech giant Amgen and pharma major AstraZeneca announced on 2 April 2012 an agreement to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab [AMG 827]), which are expected to be used to treat inflammatory diseases.

As part of the deal AstraZeneca will make an upfront payment of US$50 million and the companies will then share both costs and profits. The collaboration will provide Amgen with additional resources to optimally progress its portfolio and Amgen will benefit from the strong respiratory, inflammation and asthma development expertise of MedImmune–AstraZeneca’s biologicals arm.

Related articles

Amgen finally jumps on biosimilars bandwagon

AstraZeneca expands its generics business with Indian agreements

Source: Amgen, AstraZeneca

Reimbursement of biosimilars

The evidence required to obtain marketing authorisation for a biosimilar by the regulatory authority is not always the same as that required by the reimbursement authority [1]. This can cause problems for biosimilars manufacturers when planning clinical trials in order to obtain both marketing and reimbursement approval.

Biosimilars will not be able to use ANDA pathway to approval

FDA’s highly anticipated guidance for biosimilars finally arrived on 10 February 2012 with the release of three draft guidance documents [1]. Some have complained that the guidance is too vague, however, FDA’s denial of three citizen’s petitions have perhaps made some issues clearer.

Also noted on biosimilars: 30 March 2012

Bioequivalence of biosimilar trastuzumab to Herceptin proven in phase I trial
Biopharmaceutical company Synthon announced on 22 March 2012 that all in vitro and in vivo studies conducted so far have shown the biosimilar behaviour of Synthon’s trastuzumab in comparison with the reference product, Herceptin. The outcome of the phase I clinical trial confirmed these results, showing bioequivalence of Synthon’s trastuzumab to Herceptin. Synthon confirmed that its biosimilar trastuzumab will now enter a confirmatory phase III clinical trial in breast cancer patients.

Source: Synthon

Fujifilm and Kyowa launch biosimilars joint venture

The Japanese digital camera maker Fujifilm Corporation (Fujifilm) and biotech firm Kyowa Hakko Kirin (Kyowa) announced on 27 March 2012 that they have launched their biosimilars joint venture, which will initially focus on the development of biosimilar adalimumab.

FDA announces public hearing on biosimilars’ guidelines

FDA has announced a one-day public hearing to be held on 11 May 2012, in Silver Spring, Maryland, USA. During the meeting FDA hopes ‘to obtain input on recently issued draft guidelines relating to the development of biosimilar products.’

Pricing of biosimilars

For small molecule generics, reductions in price of around 80% have been observed after the first six months to a year of generics entry to the market in countries such as Germany, UK and the US [1, 2]. Biosimilars, however, are an entirely different entity.

Dr Reddy’s looks to biosimilars for growth

Generics giant Dr Reddy’s Laboratories (Dr Reddy’s) has been betting big on biosimilars and it seems that the risk is paying off, as the company announced record profits for the last quarter of 2011.

GE Healthcare expands biologicals business

GE Healthcare, the health business of General Electric, announced on 7 March 2012 that it had reached an agreement to acquire biologicals manufacturer Xcellerex.

Pfizer and Biocon’s biosimilar insulin deal is off

Pfizer, the world’s largest pharma company, and Indian biosimilars major Biocon announced on 12 March 2012 that they had decided to end their biosimilar insulin deal due to ‘differing priorities’.

Also noted on biosimilars: 16 March 2012

Boehringer Ingelheim expands biologicals manufacturing capacity
Boehringer Ingelheim announced on 29 February 2012 the expansion of its biopharmaceutical development and manufacturing capabilities at its cell culture and microbial sites in Biberach, Germany and Vienna, Austria. The company has invested around Euros 17 million in order to improve good manufacturing practice and to expand cell banking, process science, cell line development and quality laboratories.

Source: Boehringer Ingelheim

European biosimilars market to reach almost US$4 billion by 2017

According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper biosimilars.

Comparability studies and substitution of biosimilars

In order to demonstrate similarity between the biosimilar and the biological reference product, both products must be compared to satisfy quality, safety and efficacy requirements [1].

Biosimilar alliance between Celerion and Ricerca

Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.

WHO definitions of biosimilars

Confusion often surrounds terms used in the global field of generics and biosimilars [1].

FDA discusses biosimilars guidance

FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1]. In a webinar on 15 February 2012 FDA discussed some of the issues surrounding biosimilar products and expanded on some of the requirements contained within the guidance documents.

Biosimilars interchangeability, increased costs and burden for FDA

Biosimilars manufacturers in the US are faced with many hurdles, including untested regulatory pathways, patent challenges and manufacturing issues associated with making such complicated molecules. On top of this drugmakers also need to take into account the higher marketing costs that may be associated with biosimilars.

Oncologists urged to embrace biosimilars to help control spiraling costs of cancer care

Oncologists have been urged to embrace biosimilar drug substitution to help control the spiraling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1].

Regulation of biosimilars in the US

The US pharmaceutical industry plays a vital role in shaping the face of American health care. With major patent expiries and thin product pipelines, the industry is now considering new directions to maintain growth and stability. Biological drugs, derived from living organisms, represent a growing opportunity for big pharmaceutical firms. They command high prices, will probably have fewer firms making them than generics due to high barriers to entry, and play to the existing strengths of big pharma firms. But will the recent healthcare legislation provide the way for consistent FDA regulation? What is the most likely way in which biologicals will enter the market over the next few years?

Biosimilars: demonstrating ‘similarity’

Most biological drugs are mixtures of closely related compounds, some of which are probably more active than others. Today, the state-of-the-art manufacturing struggles to deliver material that is similar to the prior batch from the same facility and team [1]. Identical is currently not possible, therefore ‘similar’ is the route that authorities in Europe and the US are going down.

Successful completion of biosimilar infliximab programme

South Korean biotechnology company Celltrion announced on 1 February 2012 the successful completion of the company’s clinical programme for its (CT-P13) biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Quality by design in biomanufacturing

In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices [1].This replaces the previous 1987 version (updated 2004) and it is understandably a big change for some whose whole career has been dominated by the previous approach. The question is: why was a change needed and how drastic is it?

EMA risk management plans may increase prescriber confidence in biosimilars

In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescriber confidence in the compounds [1].

Registration of biosimilars in Europe and the US

Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006 [1].

Spinnovation enters biosimilar collaboration with Quantum Tessera

Dutch-based bioanalysis specialist Spinnovation Biologics (Spinnovation) announced on 24 January 2012 that it had entered into a collaboration with US-based consulting company Quantum Tessera.

Factors affecting market access of biosimilars

Growth in the use of biosimilars is being driven by the need to reduce healthcare costs, patent expiries on blockbuster originator biologicals and better-defined regulatory pathways.