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Biosimilars

FTC- Biosimilars to spur innovation and competitive prices

Biosimilars/Research | Posted 02/02/2010

In the Journal of Generic Medicines (published online 8 September 2009), Michael Wroblewski and Elizabeth Jex of the US Federal Trade Commission (FTC) write about the promise of follow-on biologics (FOBs) to spur both biological drug innovation and competitive prices.

Time for a re-evaluation of ESAs

Biosimilars/Research | Posted 01/02/2010

In an article in The New England Journal of Medicine (NEJM) by Ellis F Unger, Aliza M Thompson, Melanie J Blank, and Robert Temple, published on 6 January 2010 at NEJM.org, it is stated that it is time for a re-evaluation of erythropoiesis-stimulating agents (ESAs).

Campbell Alliance: how biotech should prepare for biosimilars

Biosimilars/News | Posted 01/02/2010

In the recently published article ‘Bracing for Biosimilars’ by Kuyler Doyle, Tony Lanzone and Fahti Khosrow-Shahi of management consultancy firm Campbell Alliance, some insight is given into what commercial and reimbursement decision makers for biotechnology companies should be doing to prepare for the arrival of biosimilars.

Modify Fc fucosylation and β-galactosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

Design out NeuGc, Fab glycosylation for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

Design out Gal-α(1,3)-Gal for biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Strategy and tools for building glycoengineered biobetter MAbs)

Strategy and tools for building glycoengineered biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Modify Fc fucosylation and β-galactosylation for biobetter MAbs, Design out NeuGc, Fab glycosylation for biobetter MAbs, Design out Gal-α(1,3)-Gal for biobetter MAbs, When is a glycoengineered biobetter commercially better than a biosimilar? and Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs)

When is a glycoengineered biobetter commercially better than a biosimilar?

Biosimilars/Research | Posted 28/01/2010

In an article by Dr Claire Morgan and Dr Daryl Fernandes of Ludger, published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter monoclonal antibodies (MAbs) through glycoengineering. (see also Modify Fc fucosylation and β-galactosylation for biobetter MAbs, Design out NeuGc, Fab glycosylation for biobetter MAbs, Design out Gal-α(1,3)-Gal for biobetter MAbs, Strategy and tools for building glycoengineered biobetter MAbs and Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs)

Ludger’s GTO-QbD: Defining glycovariant biobetter MAbs

Biosimilars/Research | Posted 28/01/2010

One area of great interest to developers, copiers and improvers of therapeutic antibodies is glycosylation, since it can significantly influence the safety and efficacy profiles of the drug. In an article by Claire Morgan and Daryl Fernandes of Ludger published in IPI of Autumn 2009, it is shown how both the original drug manufacturers and the designers of follow-on biologics could produce biobetter antibodies through glycoengineering. In particular, they examine strategies for optimising both fragment antigen-binding (Fab) and fragment crystallisable (Fc) region glycosylation to produce monoclonal antibodies (MAbs) with improved clinical performance and better commercial profiles compared to existing drugs.

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.

Minimal 12 years of biologicals data exclusivity required

Biosimilars/News | Posted 26/01/2010

As reported by Gene Quinn on IPWatchdog.com, for many months we have been hearing about the US government attempts to “reform” health care in the United States.

Teva seeks closer ties with Lonza on biosimilars

Biosimilars/News | Posted 25/01/2010

Biogenerics is a field that is becoming more and more important to Teva and the company seeks to deepen its existing ties in this area with Swiss company Lonza. Sources inform Globes that Teva President and CEO, Shlomo Yanay, CFO Eyal Desheh, and all the company’s board, flew to Switzerland for two days of meetings intended to extend the collaboration between the two companies.

Pfizer’s biosimilars strategy

Biosimilars/News | Posted 22/01/2010

“I think it is a good strategy for a large company like Pfizer that wants to be a player in generics”, Ronny Gal, a Sanford C Bernstein Analyst in New York said. “I would be surprised if they weren’t considering biogenerics”.

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.

Dr Stephen Sherwin: Biosimilars pathway with 12 to14 years of biologics exclusivity

Biosimilars/News | Posted 14/01/2010

BIO SmartBrief Editor Ashley McMaster, corresponded with Ceregene co-Founder/Chairman and BIO Board Chair Dr Stephen Sherwin to get his thoughts on what direction the biotechnology industry is headed in 2010.

Teva submits BLA for biosimilar filgrastim in US

Biosimilars/News | Posted 08/01/2010

Teva has taken its first step in the US biosimilars market. On 1 December 2009 the company submitted a Biologics License Application (BLA) with the US FDA for XM02, a biosimilar filgrastim for the treatment of severe neutropenia, a blood disorder characterised by an abnormally low number of neutrophils, the most important type of white blood cells in the blood.

Biosimilar EPO, vildagliptin and liraglutide among latest Japanese recommendations

Biosimilars/News | Posted 21/12/2009

The latest batch of positive product recommendations in Japan includes a biosimilar erythropoietin (EPO) and two novel antidiabetics, Novartis’s DPP-4 inhibitor Equa (vildagliptin) and Novo Nordisk’s GLP-1 analogue Victoza (liraglutide).

Market protection for biologicals should be less than 12 years

Biosimilars/News | Posted 18/12/2009

Giving 12 years of market protection to brand-name biopharmaceuticals would add to mounting pressure on healthcare costs and deprive patients of affordable follow-on biologics for many years, according to an editorial in The Boston Globe. It says US Congress should enact a law that provides exclusivity for more than five years but fewer than 12 to balance innovation and affordability of biotech drugs.

US bill would add six months' protection for biotech drugs

Biosimilars/News | Posted 15/12/2009

A US healthcare reform bill introduced by Senate Majority Leader Harry Reid would extend the protection some brand-name biotech medicines would get from their generic counterparts by six months. An industry executive said this would provide an incentive for companies to make products for children.

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.

Top 10 blockbuster biotech drugs: next biosimilar targets?

Biosimilars/News | Posted 02/12/2009

FierceBiotech’s Top 10 Blockbuster Biologics may be future biosimilar targets:

It may take four to five years before the first US biosimilar is a fact

Biosimilars/News | Posted 01/12/2009

It may take about four to five years for a biogeneric drug to hit the US market, even though industry experts are optimistic about the passage of pending healthcare reform legislation there by the end of 2009.

Patient safety should be addressed in biosimilars measure

Biosimilars/News | Posted 26/11/2009

US Congress should ensure that patient safety and medical efficacy are prioritised in a healthcare-reform measure that allows the use of follow-on biologics (or FOBs) according to David Nash of the Jefferson School of Population Health. Rather than just debating data exclusivity for follow-on biologics, lawmakers should also specify rules on testing these drugs and consider requiring post-market surveillance to avoid ‘unintended consequences’ that compromise patient safety, he writes.

Partnering better for biosimilars, limited growth in generics will lead to moves for innovative drugs

Biosimilars/News | Posted 26/11/2009

With six biosimilar compounds in the works and two launched in the Indian market, India's second largest generic drug maker – Dr Reddy's Laboratories – is negotiating with several multinational companies to broaden its presence in Western markets. The unveiling of a deal that may span from sharing regulatory and manufacturing expertise to distribution and detailing could be expected some time next year (in 2010). But the task of taking biosimilar drugs into developed markets will be tough and expensive as regulatory agencies will likely seek submissions on non-inferiority clinical trials that will be large-scale, typically involving close to a thousand patients or even more.

Delaware and BIO advocate call for biosimilar support

Biosimilars/News | Posted 25/11/2009

In a DelawareOnline Letter to the Editor of 2 November 2009, Delaware BioScience Association President Bob Dayton and Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood called on Delaware's lawmakers to protect consumer safety and ensure innovation of biosimilars as US Congress works on healthcare reform legislation.

Dingermann: “Use biosimilars, but don’t force patients”

Biosimilars/Research | Posted 25/11/2009

“Thanks to the stringent examinations of EMEA, patients can trust that approved biosimilars are effective and tolerable – a reassuring remark for those who are dependent on such medicines,” said Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ;Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.

Why is “the process the product” for biosimilars?

Biosimilars/Research | Posted 25/11/2009

“Why does the manufacturing process play such a prominent role in the definition of a biosimilar?” asked Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ‘Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.

Why are there suddenly ‘biosimilars’ besides ‘biologicals’?

Biosimilars/Research | Posted 23/11/2009

“Isn’t everything already complicated enough?” asked Professor Theo Dingermann of the Goethe University in Frankfurt, Germany, at the Weekend Workshop ‘Patient and Pharmaceutical Care’ of the German Union of Pharmacists Societies (Bundesvereinigung Deutscher Apothekerverbände, ABDA) held on 17–18 October 2009 in Hannover, Germany.

Biotech drugmakers get 12-year protection in US House health bill

Biosimilars/News | Posted 19/11/2009

The US House health reform bill unveiled on 29 October 2009 would grant brand-name biotech-drug manufacturers 12 years of exclusivity before generic versions of their products can rely on their safety and efficacy data. The bill also would require drugmakers to pay an estimated US$60 billion (Euros 40.13 billion) in Medicare reimbursements over the next 10 years and allow the federal government to negotiate prices directly with companies.

Mycenax to start phase III etanercept biosimilar trial

Biosimilars/News | Posted 17/11/2009

Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully completed a phase I trial in South Korea and a phase I/II clinical trial in Taiwan is in the data analysis and report preparation stage; important clinical trial milestones towards the commercial release of the drug in both regional and global markets.

Merck & Co uses its traditional strengths in biosimilars race

Biosimilars/News | Posted 16/11/2009

With sales growth for biologicals expected to outpace that in the overall pharmaceutical sector over the next few years, it is not surprising that ‘big pharma’ has been beefing up its presence in the sector through acquisitions and licensing deals.

ACRO wants clinical trials or tests for most biosimilars

Biosimilars/News | Posted 12/11/2009

On 14 October 2009, the Association of Clinical Research Organizations (ACRO) made recommendations for biosimilars legislation in a letter sent to the US Senate Committee on Health, Education Labor and Pensions, Senate Committee on Finance, House Committee on Energy and Commerce, House Committee on Ways and Means, and House Committee on Education and Labor.

Biologicals and biosimilars: how can we afford them?

Biosimilars/Research | Posted 28/10/2009

Demand for biological drugs is putting pressure on health budgets. Medical student, Mr Christopher Kelly and Consultant Physician, Dr Fraz Mir of the University of Cambridge, UK, examine in the British Medical Journal of 19 September 2009 why they are so expensive and what can be done to increase access.

US Congress urged to create a ‘real’ biosimilars pathway

Biosimilars/News | Posted 27/10/2009

On 30 September 2009, US campaigners urged US Congress to create a ‘real’ regulatory pathway for biosimilars, but researchers warn that it may take until 2011 to implement any such policies.

Hospira acquires biosimilar filgrastim rights and facility from Teva

Biosimilars/News | Posted 27/10/2009

Hospira announced on 30 September 2009 the acquisition of worldwide rights to a biosimilar version of filgrastim and an affiliated European manufacturing facility from PLIVA Hrvatska (in Zagreb, Croatia, now owned by Teva), a move that will help extend Hospira's reach and vertical integration in biosimilars.

US Senate Finance Committee accepts biosimilars reimbursement measure

Biosimilars/News | Posted 22/10/2009

The US Senate Finance Committee rejected efforts by Republican lawmakers to delay a vote on the healthcare overhaul bill until it has been revised into legal language and analysed by budget experts. The Committee, however, agreed to an amendment that would give 6% higher reimbursement for doctors who prescribe follow-on biologics.

Protalix plant-produced Enbrel biosimilar effective in preclinical models

Biosimilars/News | Posted 22/10/2009

Protalix Biotherapeutics reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company's proprietary ProCellEx technology, pr-antiTNF is a plant cell–expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF-alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model, including joint inflammation, swelling and tissue degradation. Data from the collagen-induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

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.

Quality, safety and efficacy of the epoetin alfa biosimilar Binocrit compared to Erypo/Eprex

Biosimilars/Research | Posted 13/10/2009

A detailed checklist on the quality, safety and efficacy assessment of biopharmaceuticals was published by Professors Irene Krämer, Roger Tredree and Arnold Vulto in the 2008 EJHP Practice article Points to consider in the evaluation of biopharmaceuticals (Eur J Hosp Pharm Prac. 2008;14(1):73-6). The checklist was then used by Dr Carsten Brockmeyer and Dr Andreas Seidl of Sandoz/Hexal for Binocrit, the results of which were published in Eur J Hosp Pharm Prac. 2009;15(2):34-40.

Safety study for subcutaneous epoetin alfa biosimilar Binocrit/Epoetin alfa Hexal/Abseamed suspended

Biosimilars/News | Posted 07/10/2009

In June 2009, Sandoz, the generic pharmaceuticals division of Novartis, and its subsidiary Hexal, temporarily had to suspend continuation of their clinical study into the safety of subcutaneous application of the epoetin alfa follow-on product HX575 recombinant human erythropoietin alfa for patients with renal anaemia.

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