Biosimilars

When will the US biosimilars pathway be used

Biosimilars/News | Posted 22/03/2013

FDA Commissioner Margaret Hamburg presented the latest statistics on the US biosimilar pathway during a speech at the Massachusetts Biotechnology Council’s (MassBio) Annual Meeting on 15 March 2013.

Greece says no to automatic substitution of biologicals

Biosimilars/News | Posted 15/03/2013

Greece’s Medicines Agency (National Organization for Medicines, Ethnikos Organismos Farmakon, EOF) released a document on 13 March 2013 recommending against automatic substitution/interchangeability of reference biologicals and their biosimilars.

Pharma companies sue EMA to block release of data

Biosimilars/General | Posted 15/03/2013

US-based biotech companies AbbVie and InterMune have both sued EMA in a bid to block publication of clinical trial data for their drugs.

Research on biosimilars in rheumatology

Biosimilars/Research | Posted 08/03/2013

Period: September to December 2012

Over the past decade, the availability of targeted biological therapies has revolutionized the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. However, the significant cost of these biologicals is often prohibitive and limits universal access to these effective therapeutic agents. Whereas generic drug equivalents are commercially available for many small-molecule medications, such lower cost alternatives to targeted biological therapies are not yet available in the US or the EU. The first biological therapeutics in rheumatology is now approaching patent expiration and biosimilars are now in randomized controlled trials. This means that cheaper biosimilars for the treatment of rheumatic diseases are likely to enter the market in the near future, increasing patient access to these life-changing treatments.

Japan approves second biosimilar G-CSF

Biosimilars/News | Posted 08/03/2013

Japan has granted regulatory approval to a second biosimilar granulocyte colony-stimulating factor (G-CSF).

XBiotech moves into biosimilars

Biosimilars/News | Posted 08/03/2013

US-based biotech company XBiotech announced on 26 February 2013 that the company would be expanding its portfolio to include biosimilars.

Prospects for producing follow-on biological products in Brazil

Biosimilars/Research | Posted 01/03/2013

New research shows the need for local production of biologicals in Brazil in order to offset the increasing medicines budget and reduce the trade deficit when it comes to drugs [1].

US FDA defends biosimilar substitution

Biosimilars/General | Posted 01/03/2013

US FDA Commissioner Margaret Hamburg defended the substitution of interchangeable biosimilars at the Generic Pharmaceutical Association (GPhA) Annual Meeting which was held in Orlando, Florida, USA, on 20–22 February 2013.

MS patient dies from immunogenicity to biological drug

Biosimilars/Research | Posted 01/03/2013

A Swedish woman diagnosed with multiple sclerosis (MS) appears to have died after developing unwanted immunogenicity toward the biological drug Tysabri (natalizumab), according to a report in the journal Neurology [1].

Mylan and Biocon to partner on insulin products

Biosimilars/News | Posted 01/03/2013

Generics giant Mylan announced on 13 February 2013 that it had entered into an agreement with India-based Biocon to develop and market Biocon’s biosimilar versions of three insulin analogue products.

Oncobiologics and Viropro make biosimilar deal

Biosimilars/News | Posted 01/03/2013

US-based Oncobiologics and monoclonal antibody developer Viropro announced on 25 February 2013 that they had signed a biosimilar collaboration agreement between the two companies.

Assessment of interchangeability under the BPCI Act

Biosimilars/Research | Posted 22/02/2013

The Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician [1]. The criteria for establishing interchangeability of biosimilars, despite FDA issuing three draft guidance documents, are still not clear [2].

Amgen’s response to biosimilar substitution legislation in US

Biosimilars/News | Posted 22/02/2013

Amgen, in a statement issued on 1 February 2013, has hit back at accusations that the biotech giant is attempting to limit the uptake of biosimilars in the US by backing state bills, which constrain the use of biosimilars.

The ethics of biosimilars

Biosimilars/Research | Posted 22/02/2013

Biosimilars in the EU have to undergo a strictly regulated comparability exercise against the reference medicinal product on the physicochemical, analytical, functional, non-clinical and clinical level. Only if a biosimilar is a close copy of the reference medicine will it be approved as a biosimilar [1]. Despite this fact, however, ethical issues have been raised on the use of granulocyte colony-stimulating factor (G-CSF, filgrastim) in healthy volunteers by the European Group for Blood and Marrow Transplantation (EBMT) and the World Marrow Donor Association (WMDA).

Merck makes biosimilars deal with Samsung Bioepis

Biosimilars/News | Posted 22/02/2013

Pharma Giant Merck announced on 20 February 2013 that it had made a deal to develop and commercialize biosimilars with Samsung Bioepis.

Medicines spending in Brazil

Biosimilars/Research | Posted 15/02/2013

The Brazilian pharmaceutical market is the third largest in the Americas region, behind the US and Canada; it ranks first in the Latin American region. Pharmaceutical demand will continue to rise, fuelled by increasing disposable income. Despite this positive outlook, the trade deficit in Brazil grew from US$700 million at the end of the 1980s to a cumulative US$7.13 billion in 2008. In 2008 alone, Brazil imported US$1.4 billion in vaccines, serum and blood products, while exporting US$37 million in medicinal products with low added value [1].

Biosimilars to replace 70% of chemical drugs

Biosimilars/General | Posted 15/02/2013

Biosimilars will replace some 70% of global chemical drugs over the next couple of decades, according to industry experts. This replacement will occur due to the better safety profiles of biosimilars compared to chemical drugs and the fact that many originator biologicals will lose their patent protection in the coming years, according to Mr Appaji, Director General of Pharmaceuticals Export Promotion Council of India (Pharmexcil).

AMAC and GPhA hit back at Big Pharma over biosimilars

Biosimilars/News | Posted 15/02/2013

The Association of Mature American Citizens (AMAC) and the Generic Pharmaceutical Association (GPhA) have reacted strongly to the actions by Amgen and Genentech, which aim to make it more difficult for patients to get access to biosimilar medicines [1].

Biologicals boom

Biosimilars/Research | Posted 15/02/2013

Researchers predict that the present list of top 10 blockbuster drugs will change dramatically by 2014. The predictions are that by 2014 biological drugs will topple the present market leaders Pfizer’s Lipitor (atorvastatin) and Sanofi’s Plavix (clopidogrel), both of which are small molecule chemical entities [1].

Biotech firms try to limit biosimilar substitution in US

Biosimilars/News | Posted 08/02/2013

FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.