Biosimilars/General

American dermatologists update position statement on biosimilar substitution

Biosimilars/General | Posted 16/11/2012

On 3 November 2012, the American Academy of Dermatology (AAD) updated its position statement on generics and biosimilar substitution to reflect its views, in particular on interchangeability* and naming of biosimilars.

EMA definitions of generics and biosimilars

Biosimilars/General | Posted 21/10/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem. The members of the Biosimilar Medicinal Products Working Party at EMA have recently expressed the need to propose a more precise definition for biosimilars due to problems arising from imprecise usage of the term in the scientific literature and elsewhere [1].

Biosimilars applications under review by EMA

Biosimilars/General | Posted 19/10/2012

Last update:  11 January 2013 

EMA is the body responsible for approval of biosimilars within the 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’.

Teva asks FDA to delay approval of Biogen’s MS drug

Biosimilars/General | Posted 18/01/2013

Teva Pharmaceutical Industries (Teva) has petitioned FDA not to approve Biogen Idec’s (Biogen’s) investigational pill for treatment of multiple sclerosis, BG-12 (dimethyl fumarate), citing safety concerns.

EMA publishes revised biosimilar Q&A document for patients

Biosimilars/General | Posted 05/10/2012

On 27 September 2012 EMA published its revised Questions and Answers (Q&A) document on biosimilar medicines aimed at patients and the general public.

Naming and interchangeability of biosimilars raised in new survey

Biosimilars/General | Posted 05/10/2012

The contentious issues of naming and interchangeability of biosimilars in the US have been raised once again, as a result of a survey carried out by the Alliance for Safe Biologic Medicines (ASBM). The survey, released on 13 September 2012, examined physician practices and perspectives with regard to identification and substitution of biosimilars. These remain issues that are as yet unresolved by FDA.

Also noted on biosimilars: 30 March 2012

Biosimilars/General | Posted 30/03/2012

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

FDA urged to exclude plasma protein therapies from biosimilar pathway

Biosimilars/General | Posted 03/08/2012

FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a mandate to create a new abbreviated process for the approval of biosimilars under the Biologics Price Competition and Innovation Act of 2009, which was part of the new healthcare reform law passed in March 2010 [1]. This potentially brings cheaper products to market sooner, and so increases the availability of affordable health care. However, it also means that manufacturers applying for approval for new biosimilars may be able to skip clinical testing if they can demonstrate sufficient similarity with reference products.

US supreme court ruling means biosimilars pathway safe

Biosimilars/General | Posted 06/07/2012

On 28 June 2012 the US Supreme Court ruled in favour of the bulk of the Affordable Care Act, meaning that the biosimilars pathway, which is part of the act, is now also safe.

US Supreme Court looks set to challenge Affordable Care Act

Biosimilars/General | Posted 18/05/2012

The United States Supreme Court is reviewing the constitutionality of the provision in the Affordable Care Act providing that individuals should take personal responsibility for paying for their health care by obtaining health insurance or pay a fine. The move could mean that the Supreme Court rejects the whole healthcare law, including the biosimilars pathway created by the healthcare reform.

Biosimilars approved and marketed in The Netherlands

Biosimilars/General | Posted 01/06/2012

Last updated: 1 June 2012

The Dutch Medicines Evaluation Board (MEB) – College ter Beoordeling van Geneesmiddelen (CBG) – is responsible for the approval of marketing authorisation of medicinal products including biosimilars in The Netherlands.

FDA’s public hearing on biosimilars draft guidances

Biosimilars/General | Posted 25/05/2012

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted.

Biosimilars approved and marketed in Belgium

Biosimilars/General | Posted 18/05/2012

Last updated: 18 May 2012 

The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in January 2007, is the official authority for medicines and health products in Belgium and is also responsible for authorising biosimilars in Belgium [1]. This is carried out via the EU procedures (centralised, national, mutual recognition or decentralised) and following EMA guidelines for biosimilars.

Also noted on biosimilars: 11 May 2012

Biosimilars/General | Posted 11/05/2012

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

Also noted on biosimilars: 13 April 2012

Biosimilars/General | Posted 13/04/2012

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

Also noted on biosimilars: 6 April 2012

Biosimilars/General | Posted 06/04/2012

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

BIO and GPhA support biosimilar and generic user fees

Biosimilars/General | Posted 06/04/2012

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

Biosimilars will not be able to use ANDA pathway to approval

Biosimilars/General | Posted 30/03/2012

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.

FDA announces public hearing on biosimilars’ guidelines

Biosimilars/General | Posted 23/03/2012

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.’

Also noted on biosimilars: 16 March 2012

Biosimilars/General | Posted 16/03/2012

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

WHO definitions of biosimilars

Biosimilars/General | Posted 09/03/2012

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

Biosimilars interchangeability, increased costs and burden for FDA

Biosimilars/General | Posted 02/03/2012

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.

Quality by design in biomanufacturing

Biosimilars/General | Posted 17/02/2012

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?

Top developments in biosimilars during 2011

Biosimilars/General | Posted 13/01/2012

Over the past year, a lot has happened in the biosimilars industry.

FDA biosimilar user fees meeting

Biosimilars/General | Posted 16/12/2011

FDA announced a public meeting to be held on 16 December 2011 to discuss its recommendations for the agency’s biosimilars user fee programme for 2013–17.

Health Canada definitions of generics and biosimilars

Biosimilars/General | Posted 16/12/2011

Attention has been brought to the fact that there is confusion surrounding terms used in the global field of generics and biosimilars. Some of this confusion has been attributed to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.

Speed to market critical in biosimilar development

Biosimilars/General | Posted 18/11/2011

For companies looking to develop biosimilars speed to market is critical, but this must not be done by sacrificing product quality, according to a report from Contract Research Organisation (CRO) Quintiles. The most successful biosimilar companies will be those who collapse their clinical, commercial, and regulatory thinking into a streamlined cohesive function in order to expedite commercialisation and optimise market access.

FDA definitions of generics and biosimilars

Biosimilars/General | Posted 18/11/2011

Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem.

The source of some of this confusion is due to authorities in various regions of the world defining terms differently and other instances are due to a misunderstanding of the actual nature, characteristics, and method of research and manufacture of these biological products.

Biobetter of trastuzumab on the horizon

Biosimilars/General | Posted 14/10/2011

TrasGEX, which is currently under development by German biopharma company Glycotope, is shaping up to be an improved version (or biobetter) of Roche’s blockbuster cancer drug Herceptin (trastuzumab). Trastuzumab targets the HER2 receptor, commonly overexpressed in a variety of cancers, such as HER2-positive breast and stomach cancer.

Five years of bioequivalence data from Cetero questioned

Biosimilars/General | Posted 16/09/2011

FDA is challenging five years of bioequivalence and other studies conducted at Cetero Research’s Houston facility in the US. This could affect both originator and generics companies alike, putting into question data provided to FDA to support new drug applications (NDAs) and abbreviated new drug applications (ANDAs).

Biotech growth and biosimilar opportunities in India

Biosimilars/General | Posted 02/09/2011

The domestic biotechnology industry in India has seen rapid growth during 2010 and India is poised to attain a position of leadership in the biosimilars market according to reports from Ernst & Young India and Frost and Sullivan.

FDA and biosimilars: update on key themes

Biosimilars/General | Posted 26/08/2011

Since the existence of a legal pathway for biosimilars was made possible by the signing of the 2009 Biologics Price Competition and Innovation (BPCI) Act in 2010 by President Barack Obama, FDA has declared itself ‘open for business’ for biosimilars [1]. But what is the thinking of FDA and what should we expect from any guidance on biosimilars?

FDA and biosimilars: process update

Biosimilars/General | Posted 19/08/2011

Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US [1]. So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?

Current status of biosimilar development

Biosimilars/General | Posted 01/07/2011

Widespread therapeutic use of biological pharmaceutical products appears to be inevitable. Nevertheless, the law governing approval of biosimilar products in the US is still not in place. The size of the biologicals market and impending patent expiries, however, are making approval of a practical pathway for biosimilars more urgent.

Market opportunities for biosimilars

Biosimilars/General | Posted 17/06/2011

Although growth in annual spending on medicines is set to reduce, there is still a huge market out there and spending on biosimilars is expected to increase in the coming years.

Enoxaparin biosimilar or not

Biosimilars/General | Posted 06/06/2011

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.

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.

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.

More debate over the exclusivity period for biological in the US

Biosimilars/General | Posted 10/06/2011

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).

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

Biosimilars/General | Posted 20/05/2011

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.

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.

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.

US Senate healthcare bill preserves biologicals exclusivity, but charges annual drugmaker fees

Biosimilars/General | Posted 10/12/2009

The recently released US Patient Protection and Affordable Care Act, H.R. 3590, will ensure that all Americans have access to quality, affordable health care and will create the transformation within the healthcare system necessary to contain costs.

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.

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.

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.

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.

Highs and lows for biosimilars during 2009/2010

Biosimilars/General | Posted 17/09/2010

A lot has happened in the biosimilars’ industry during 2009/2010.

Is US Congress poised to hinder biosimilars market entry?

Biosimilars/General | Posted 19/01/2010

A proposal by US Democratic Representative Anna Eshoo included in the US House health reform bill, would give developers of innovative biomedical drugs 12 years of data exclusivity from generic competition, significantly extending their patent rights, writes Los Angeles Times columnist Michael Hiltzik. Ms Eshoo said her proposal would give original makers of biotech drugs adequate profit to discover new treatments without discouraging generic drugmakers from working on follow-on biologics.

Innovation over imitation: New FOBs technologies, players

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, tables are presented on new technologies for creating ‘biobetter’ follow-on biologics (FOBs) and potential ‘Big Pharma’ players in FOBs.

Innovation over imitation - How to deliver FOBs on the bottom line

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Innovation over imitation - Charting the FOBs landscape

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Innovation over imitation: Tools to compete and win with ‘biobetter’ FOBs

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Innovation over imitation: High-cost biosimilar FOB development, slow uptake

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Innovation over imitation: ‘Biobetter’ follow-on biologics

Biosimilars/General | Posted 03/02/2010

In an article by Xencor President and CEO Bassil Dahiyat, published in Pharmaceutical Executive on 4 November 2009, the development of ‘biobetter’ follow-on biologics (FOBs) — optimised versions of pioneer drugs that have improved pharmaceutical properties but carry only minor changes in structure — is discussed.

Bionomics of biosimilars – India’s next big cash cow?

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. According to her, however, players have many knots to untangle before they can have a firm grip over the economics of the market.

Bionomics of biosimilars – Indian opportunities

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

Bionomics of biosimilars – EU and US markets not easy for India

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market, she warns.

Bionomics of biosimilars - Indian options for investors

Biosimilars/General | Posted 02/03/2010

As reported by Ms Nayantara Som in BioSpectrumIndia of 13 January 2010, biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market.

Global Industry Analysts: Global biosimilars market to exceed US$2 billion by 2015

Biosimilars/General | Posted 09/04/2010

On 24 March 2010, Global Industry Analysts (GIA) announced the release of a new report, entitled ‘Biosimilars: A Global Strategic Business Report’

Biosimilars mean competition for biologic brands

Biosimilars/General | Posted 09/04/2010

The historic passage of two US healthcare reform bills on 21 March 2010, including a US Senate bill with an approval pathway for biosimilars, means biologic brands could see rivals replicate and market similar products, writes Mr Marc Iskowitz in Medical Marketing & Media. According to him, the new legislation, signed by US president Mr Barack Obama on 23 March 2010, lays out a series of requirements for the FDA to consider follow-on biologics (FOBs) applications.

12 years exclusivity workable for patients; not anticompetitive

Biosimilars/General | Posted 26/01/2010

On IPWatchdog.com Gene Quinn distinguishes facts from fiction about biosimilars.

Will there be unfair delays for the entry of biosimilars?

Biosimilars/General | Posted 15/10/2009

As pointed out by Managing Editor, Ms Maria Fabiana Jorge, in the Editorial of the Journal of Generic Medicines, Volume 6, Issue 4 of August 2009, countries around the world define the future pharmaceutical market, we must learn from the past to avoid making the same mistakes or falling into new ones. Unfortunately, the current system has serious flaws and it seems that we are moving towards creating others in the new one. It is essential that governments, the pharmaceutical industry and civil society throughout the world work closely to strike a better balance between innovation and access in the context of biotechnology medicines.