Biosimilars

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.