Monthly Archives: September 2013

September 24,2013 | By Márcio Barra

Kadcyla (ado-trastuzumab emtansine, or T-DM1), from Roche/Genentech, was approved on the September 2013 meeting of the EMA’s Committee for Medicinal Products for Human Use. This is the drug’s third approval in a major territory, following the US FDA’s approval back in February and in Japan for the treatment of HER2+ positive inoperable or recurrent breast cancer.

Kadcyla is a therapy for patients with HER2-positive, late-stage (metastatic) breast cancer, consisting of the antibody trastuzumab, connected to a drug called DM1, from ImmunoGen. The medicine, which comes in two dosage forms, 100 mg and 160 mg, was approved for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and chemotherapy, separately or in combination.

HER2 is a protein encoded by ERBB2, a proto-oncogene located in chromosome 17. Over-expression of this proto-oncogene occurs in roughly 30% of breast cancers, and the increased amount of HER2 protein contributes to the breast cancer cell growth and survival.

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September 18,2013 | By Márcio Barra

The President of APIFARMA, João Almeida Lopes

The President of the Portuguese Association of Pharmaceutical Industries (APIFARMA), João Almeida Lopes, revealed today that the public expenditure on medicines compared to the Gross Domestic Product (GDP) will reach 1.13% this year, higher than the 1% target set by Troika. This was disclosed on a conference organized by APIFARMA on “biopharmaceutical and biosimilars innovation”, where João Almeida Lopes told the reporters that the goal of one percent of GDP set by the government under the ongoing economic program is ‘unattainable’.

“That value is not attainable and will not be achieved. There are values ​​that are not feasible. In spreadsheets everything fits, but then the reality is something else”. “It is a goal decontextualized from reality,” he stressed, adding that this was initially only be for the outpatient market and only later was it imposed for hospital expenditure with medicines.

João Almeida Lopes estimates that this year public expenditure on medicines should reach 1.13% of GDP, missing the target by 0.13%, a value that is still “in line with the European targets”.  The values for the 2013 agreement between the Ministries of Health, Economy, Employment, Finances and the Pharmaceutical Industry for the sustainability of the National Health Service are still being discussed at the moment. A similar deal was signed in 2012, were pharmaceutical companies agreed to cooperate in reducing drug expenditure by 300 million euros compared to 2011, through cuts of 170 million euros in public expenditure of the hospital market and 130 million euros in the outpatient market.

September 16,2013 | By Márcio Barra

Image from WhoWhired

Remsima (infliximab), a biosimilar of Remicade, was approved by EMA’s CHMP last June. Now, The European Comission has granted the final authorization for commercialization for what is the first biosimilar monoclonal antibody to be approved by the EC for  rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and and psoriasis.

Remsima is from Hungarian company Egis pharmaceuticals and the Korean company, Celltrion Group, who both signed an agreement in 2010 for the distribution of 8 biosimilar products. Remsima is the first product to be launched. In this deal, Egis is to distribute  biopharmaceutical products developed and manufactured by Celltrion.

Egis said in a statement that it would now launch Remsima in Central and Eastern European countries.

Remicade, the original product from Johnson & Johnson’s, is a monoclonal antibody that has been authorised in the European Union since 1999. Remicade generates $6 billion in annual sales, making it J&J’s biggest selling drug. Being a monoclonal antibody, this approval from the European Comission is remarkable as these are tremendously complex molecules. The molecule, Infliximab, is a monoclonal antibody that bings and blocks TNF-alpha, a pro-inflammatory factor released during autoimmune diseases.

The first biosimilar ever approved in Europe dates back to 2006, when Omnitrope (somatropin) was approved. Since then, a total of 12 biosimilar products were authorized. This decision is expected to set a precedent for future approvals of biosimilar antibodies, paving the way for a potentially profound shift in the biotech landscape – especially when  twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020.