Medizone Home

MabThera SC now approved in EU for patients with non-Hodgkin lymphoma

Roche announced today that the EU Committee for Medicinal Products for Human Use (CHMP) recommended that the European Commission approve MabThera (rituximab) 1400mg solution for subcutaneous (SC) injection for the treatment of patients with common forms of non-Hodgkin lymphoma (NHL).

“We are excited the MabThera SC data confirm the efficacy and safety of a significantly shortened treatment time,“ said Sandra Horning, M.D., Chief Medical Officer and Head, Global Product Development. “We are confident that reducing treatment to approximately five minutes with MabThera SC will be an improvement for patients and healthcare professionals alike.”

Currently, MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be delivered over approximately five minutes and comes as a ready-to-use, fixed dose, which reduces pharmacy preparation time and overall impact on hospital resources.

The CHMP opinion is based primarily on data from the phase III SABRINA study. Roche expects a final decision from the European Commission in the coming months.

Source: Roche press release


Medizone supports “Wings for Life” Foundation

The driving forces behind Wings for Life are the two-time motocross world champion Heinz Kinigadner and the founder of Red Bull, Dietrich Mateschitz. In 2003, Kinigadner’s son Hannes had a tragic accident at the age of 19 which left him tetraplegic.

Moved by the dreadful injury, Kinigadner and Mateschitz invited leading scientists from across the world to come to Salzburg. It soon became clear that, contrary to common opinion, there is legitimate reason to hope that traumatic spinal cord injury can be cured. Ground-breaking discoveries made by Prof. Dr. Sam David in 1981 and by Prof. Dr. Martin Schwab in the early 1990s showed that injured nerve cells in the spinal cord are capable of regeneration after specific types of treatment.

Kinigadner and Mateschitz soon realised that research into spinal cord injury was underfunded. Paralysis is not considered a widespread condition and therefore investing millions in research to help a relatively small number of people was generally considered an unprofitable endeavour.

This realisation prompted Kinigadner and Mateschitz to set up the Wings for Life research foundation – with the goal of finding ways to cure all people affected.

100% of donations are used to fund basic research as well as preclicincal and clinical studies of promising new therapies and drugs. The administration costs are borne entirely by Red Bull.


„My grandfather spent more than half of his life in a wheel chair after an accident. A friend of my son is paralyzed since years after a ski accident. It can happen to anyone of us. The question is not whether effective treatments and cures will be found, but when they will be found!
We are proud to support Wings for Life!“

Gerhard Hoerl
Managing Director – Medizone Germany

Biocon-Mylan’s Biosimilar of Herceptin approved in India

Biocon, India’s largest listed biotechnology company, informed it had received marketing authorisation from the Drugs Controller General of India (DCGI) for its trastuzumab biosimilar, being developed jointly with US’ Mylan, for the treatment of HER2+ metastatic breast cancer. The product will be launched during the last quarter of this financial year.

This is the first approval for a biosimilar product developed by Biocon and Mylan, which joined the project in 2009. The product is a biosimilar to Swiss pharma giant Roche’s Herceptin, used for the treatment of this type of breast cancer. Biocon and Mylan will sell products under CANMAb and Hertraz brand, respectively. Biosimilars are independently developed follow-on versions of medicines after their patent has expired.


Apotex Canada received its first Biosimilar registration in Europe of Amgen’s blockbuster cancer treatment filgrastim!

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.

New EU GDP Guidelines of 07.03.2013 – Update 08.09.2013

The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013.

With the project “GDP-Readiness” Medizone checked all SOP’s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the action items we performed in the last six months:

  • All of our established and proven transport partners were re-qualified and Quality Agreements have been established, where they did not exist in the past.
  • The preparation for more stringent rules on transport and temperature monitoring during transport has been finalized and implemented.
  • The Cold-Chain-Procedures have been expanded to cover Controlled-Room-Temperature, too. SOP “Cold Chain” got “Thermo-Sensitive Pharmaceuticals”
  • All SOP’s have been reviewed to ensure full compliance to the new Version of the Guidelines.
  • CAPA-procedures – as we still did in the past – have been described in the new SOP “CAPA (Corrective And Preventive Action)”
  • Master Data Procedures – that we still handled according to the four-eye-principle in the past – have been described in the new SOP “Master Data”.

To be continued…

With our procedures we try to get even better day by day to provide better service to our clients.

Celltrion files for approval of trastuzumab (Herceptin) biosimilar (CT-P6) in Korea

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

EMA revised the biosimilar guideline and public consultation is now open

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.

Biosimilars require more robust analytical data

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 launches Enbrel biosimilar in India

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…

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.