Apotex’s version of filgrastim received regulatory approval from the European Commission.

Out-of-patent filgrastim, a biologic drug branded as Neupogen by Amgen and as Grastofil by Apotex, is used to boost production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy.

The product will be marketed by Stada in nearly all European Union countries. Stada plans to start sales next year, hoping to win a slice of the 1 billion euro ($1.4 billion) European filgrastim market.

Stada has been among the first European generics makers to invest in biosimilars, winning European approval for a version of aneamia treatment epo as early as 2007, but the business has so far failed to make meaningful contributions to group sales.

On June 4th Celltrion officially announced that it has filed for Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration) approval of CT-P6 with same indications of the original product for breast cancer and metastatic gastric cancer.

Upon receiving MFDS approval for CT-P6, Celltrion plans to launch its second mAb biosimilar product into the Korean pharmaceutical market. Celltrion previously filed for approval of their first biosimilar product Remsima in February 2012 and received approval in July of the same year.

The original product of CT-P6, which is trastuzumab, has generated sales over USD 6.3 billion globally in 2012. CT-P6 is the first trastuzumab biosimilar to enter the regulatory approval procedure.

Celltrion received approval for its first biosimilar product Remsima (biosimilar version of Remicade-infliximab) in July 2012 from the MFDS. In addition, currently, Remsima has been approved by various countries abroad and sales of Remsima have commenced in these foreign markets.
Source: Celltrion press release

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.