The European Medicines Agency (EMA) has recently published an updated biosimilars guideline for consultation that outlines the general principles that industry must take into account when developing a product and making an application to the agency. While FDA is still arguing the pathway and States are taking actions to restrict and control biosimilar entry in the US, EMA, the pioneer regulatory body for biosimilars and the watchdog of Europe, again released a guideline to describe the steps and improve the processes within the EU. There are some critical changes in the new guideline. Reference products, should still be authorized in the European Economic Area but as expected, EMA now says that: “with the aim of facilitating the global development of biosimilars and to avoid unnecessary repetition of clinical trials, it may be possible for an Applicant to compare the biosimilar in certain clinical studies and in vivo non-clinical studies (where needed) with a non-EEA authorised comparator (i.e. a non-EEA authorised version of the reference medicinal product) which will need to be authorised by a regulatory authority with similar scientific and regulatory standards as EMA (i.e. ICH countries).” The consultation of the draft guideline is open until the end of October 2013 and the guideline can be reached from here.

At Biosimilar Drug Development conference recently held in London, Mark McCamish / Head Global Biopharmaceutical Development at Sandoz presented latest trends of the ever changing regulatory framework for Biosimilars and stressed the need for more robust biosimilarity data. This trend follows the release of the new FDA Guidelines and will have its impact on EMA as well. The better a Biosimilar can be characterized the less stringed will be requirement for subsequent clinical trials and by thus will help to reduce overall cost. Medizone Germany is specialized in the sourcing of reference products and can offer their service to existing and potentially new developers of Biosimilars.

Cipla has launched the first biosimilar of Pfizer and Amgen’s rheumatic disorder blockbuster Enbrel in India. The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be manufactured by China’s Shanghai CP Guojian Pharmaceutical Co. The drug signals Cipla’s entry into the biologic segment, it said, “offering an option to patients suffering from rheumatic disorders at a lower cost”. The Mumbai-based group’s medical director Jaideep Gogtay said “the higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients”. He added that introducing Etacept at a lower cost (at 6,150 rupees, 30% less than the innovator product) “will enable access of this drug to a greater number of patients in India”.

EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs.

European Biosimilars developers will be glad to hear that the reference product of the Originators biologic, can be purchased outside the EU for comparative pivotal studies. The decision was made public by the EMA recently and the new policy should be implemented next year 2013 in the updated overarching “similar medicinal products” guideline CHMP/437/04. With regard to the acceptance of US-sourced RMPs, a close collaboration with the FDA is foreseen to ensure harmonisation of requirements. This will be welcomed by US driven companies. Through our extensive network of approved supply partners we are be able to offer comparators from outside the EU at high quality and competitve prices.

We are all anxiously waiting for the final version of the new EU GDP Guidelines that are expected for release early 2013. We attended a seminar end of November in Munich to hear the latest news from the Head of our responsible inspection authorities. It looks like there will be several adaptions vs. the initial draft. We have already started to prepare ourselves for the more stringent rules on transport and temperature monitoring during transport by working on new SOP´s.

The shortages for several oncological injectable products continue in Europe, US and several other countries. We do have close cooperation with several reputable Generic Manufacturers and deliver products with full documentation at reasonable prices. Last year we supplied bigger batches of Irinotecan, Paclitaxel, Docetaxel, Doxorubicin and Carboplatin to our customers and helped them to overcome product shortages or potential delays in clinical trials.

Medizone´s partner in Russia recently opened a state-of-the-art, GxP compliant depot for study medications and clinical trial material located near Moscow not far away from Domodedovo airport. Our partner has storage capabilities in all temperature conditions: ambient, chilled, frozen and LN2. The services cover all logistical aspects:

• Local sourcing of comparator products and clinical trial material
• Importation
• Labeling / relabeling
• Temperature controlled storage and distribution
• Destruction
• Exportation

We have performed successfully many local sourcing project for comparators. We can provide CoA´s and batch info prior to purchase.