Generics and biosimilars Initiative

Building trust in cost-effective treatments

Sign up
eng / esp

Biosimilars

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.

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.

1
...
52
53
54
55
56