Monthly Archives: February 2015

February 25, 2015 | By Márcio Barra


Celltrion´s biosimilar of the biologic Remicade (infliximab), will be launched in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden under the brand name Inflectra by Hospira, and in Germany, Italy, Britain, the Netherlands, Belgium and Luxembourg under the brand name Remsima by privately-held Indian drug company Mundipharma.

Remicade Biosimilars have been available in certain smaller markets in Europe, such as Norway, for several months, but this is the first time a biosimilar of a monoclonal antibody, which are molecules with considerable complexity, will be launched into major markets. The price discount is estimated to be around 20-30 percent cheaper than the original drug, as stated by Paul Greenland, head of biologics at Hospira.

Biosimilars serve a similar purpose as generic drugs, but with some key differences and more stringent requirements, owing to the differences in replicating large molecules compared to smaller molecules. Seeing as biologic drugs are produced from living organisms, the production processes are quite sensitive to changes in the manufacturing processes, and thus is it very hard to create an exact replica of the original molecule. Biosimilars must be shown in clinical trials to be close enough to the original molecule to provide the same therapeutic effect.

Hospira was acquired by Pfizer earlier this month in a $17 billion deal , with the potential to establish a strong presence in the biosimilar market being one of the key drivers behind the decision.

Inflectra, or Remsima, was approved by EMA’s CHMP in June 2013. Final authorization from the European Comission for commercialization arrived in September 2013. The drug was 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.

Remicade, which is jointly owned by Merck and Johnson & Johnson of the US, 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 binds 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.



February 25, 2015 | By Márcio Barra


According to a report by Diário Digital, three new drugs to treat multiple sclerosis are awaiting reimbursement approval from INFARMED ( the portuguese national competent authority) and shall be made available to portuguese patients later this year.

In a statement from Dr.  Maria José de Sá, coordinator of the Demyelinating Diseases Clinic of the São João Hospital, patients will soon have access to “two oral drugs in tablet formulation ‘to replace intramuscular or subcutaneous auto-injectable drugs. The two oral drugs are Fampyr (fampridine), and Tecfidera (dimethyl fumarate).

Fampyr was approved last year by INFARMED, for the Improvement of walking in patients with Multiple Sclerosis. The cost of the monthly treatment (1 tablet BID) is 177.15 euros, with a full 100% reimbursement. The drug´s approval by the European Medicines Agency was in 2011.

Tecfidera is indicated for relapsing-remitting Multiple Sclerosis, and the drug was quite a hit when it launched in the US in 2013. The drug became the most-prescribed pill, easily beating its oral competition shortly after launch – Sanofi’s Aubagio (teriflunomide) and Novartis’ Gilenya (fingolimod) – reaching 13% of market share on its own compared with their combined 12.3%. Tecfidera is currently one of the main drivers of growth for Biogen Idec.

The drug´s success lies in its safety profile. Aubagio carries the risk of liver injury and birth defects, while Gilenya, although first to reach the market, has been held back by heart safety concerns. Tecfidera side effects include a decrease in a person’s white blood cell count, alongside nausea, vomiting, and diarrhea, which tended to get better over time without stopping the drug. The drug was also cheaper when it launched in the US than Gilenya, but was more expensive than Aubagio. Both Fampyr and Tecfidera are commercialized by Biogen Idec, and they are currently undergoing cost effectiveness analysis by INFARMED.

The third drug is an injectable monoclonal antibody, called Lemtrada (Alemtuzumab), from Genzyme, for the treatment of relapsing-remitting multiple sclerosis. Owing to its status as a biologic drug, the drug will have a higher cost and administration will occur solely on an hospital setting. The drug´s use is reserved for very severe cases. Lemtrada was approved by the European Commission in 2013, and the drug has a unique dosing and administration schedule consisting of 2 annual treatment courses. The first course is given as an intravenous infusion over 5 consecutive days, and the second over 3 days 12 months later.

This coming Friday and Saturday (February 27 – 28) is the Third International Porto Congress of Multiple Sclerosis, held in the Demyelinating Diseases Clinic of the São João Hospital. Innovative treatments are one of the issues highlighted for discussion, alongside pediatric multiple sclerosis and the costs of the disease in Europe.

February 10, 2015 | By Márcio Barra

INFARMED published in its news bulletin a study providing an overview of the consumption trends of anticoagulant therapy in Portugal, from 2010 to 2013.  1 The report shares some interesting numbers, especially when considering the new molecules that have been released during the timeframe, namely the new oral anticoagulants (NOACs). The full version is supposedly available in the regulators website, but unfortunately I was unable to find it.

In the last 5 years, the NOACS, of which there are the direct inhibitors of factors IIa (Dabigatran, commercial name Pradaxa) or factor Xa (Rivaroxaban, commercial name Xarelto, and Apixaban, commercial name Eliquis), have been granted European and US marketing authorization for the prevention of thrombotic events, such as stroke and systemic embolism, in high-risk adult patients. A third factor Xa inhibitor, Edoxaban (commercial name Savaysa) was recently approved in the USA by the FDA for the prevention of stroke and embolic events in patients with non-valvular atrial fibrillation. These drugs overcome some limitations associated with the traditional oral and parenteral anticoagulants, such as Warfarin and Low Molecular Weight Heparins, such as frequent monitoring of INR. As for efficacy, NOACs’ efficacy across a whole spectrum of prothrombotic conditions is, at least, non-inferior to the standard care. 2

Concerning safety, as any other new drug in the market, there are still unknowns associated with these drugs, alongside the fact that, unlike established agents such as Warfarin, at the moment there is no antidote available to reverse the anticoagulant effect. (Boehringer Ingelheim has an antidote currently in clinical development, idarucizumab. Initial Phase I study results appear promising. 3

Read More