Menu

Biosimilars/News

picture26

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.

picture12

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:

picture08

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.

picture05

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.

picture06

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.

picture04

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.

picture24

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.

picture19

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.

picture17

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.

picture15

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.

picture01

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.

picture26

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.

picture22

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.

China to globalise its successful domestic biosimilars market

Biosimilars/News | Posted 05/10/2009

The fearsome darling of the pharmaceutical industry, China, has marketers salivating over the 20%-plus annual growth, which could position the country as the world’s third-largest pharmaceutical market by 2020. Researchers are also gushing over the local clinical research organisations and the compounds they churn out. The Chinese government proclaimed that biotechnology will be a key pillar industry, and the State Council announced a two-year US$9.2 billion (Euros 6.4 billion) technology development plan earlier this year.

US House panel adopts 12 years’ biologicals exclusivity

Biosimilars/News | Posted 01/10/2009

The powerful US House Committee on Energy and Commerce (HCEC) has voted to give branded biological drugs 12 years’ market exclusivity from generic competition, but also to ban ‘pay-for-delay’ settlements.

Biosimilars to be held up 0 to 13.5 years under new US bill

Biosimilars/News | Posted 01/10/2009

A bill submitted to the US Senate proposes granting up to thirteen and half years of exclusivity to biological drugs. Under the plan, the branded products would receive at least nine years of exclusivity, plus additional time depending on potential innovations made to the drug.

picture02

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.

Current European biosimilars market may suggest US threat to biotech will be limited

Biosimilars/News | Posted 14/09/2009

Though the threat of biosimilars is a hot topic in the US biotech market, their introduction in Europe may reveal that their effects will be limited.

Dutch health insurers obtain biosimilars green light

Biosimilars/News | Posted 14/09/2009

Health insurers in The Netherlands are allowed to include biosimilars in their preference policies, the Dutch health ministry has confirmed for the first time, signalling Europe's growing acceptance of these products.

Biotech drugs need adequate patent protection

Biosimilars/News | Posted 14/09/2009

The US government could establish “a properly constructed biosimilars pathway” by providing original developers of biotech drugs with at least 12 years of intellectual property protection to allow them to recover their investments in such treatments, writes former Vermont Governor, Mr Howard Dean, in his commentary. Two bills for follow-on biologics introduced in the House and Senate "include a balanced approach that protects patient safety and encourages research that helps bring new, more advanced treatments – and even cures – to patients around the world," Mr Dean writes.