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Samsung Bioepis submits Enbrel biosimilar to EMA

Samsung Bioepis Co., Ltd., announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4 has been validated and accepted for review by European Medicines Agency (EMA).

The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA).

In Europe, Enbrel is indicated for the treatment of a number of rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If authorized by the EMA, SB4 could be available for use in all of the same indications as Enbrel.

“This MAA validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars. More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe” said Christopher Hansung Ko, chief executive officer of Samsung Bioepis.

If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec. It will also be produced at the company’s manufacturing facility in Hillerød, Denmark which is one of the largest biologic manufacturing facilities in the world.

In addition to the European filings, Samsung Bioepis intends to move forward with additional applications for regulatory approvals in other territories worldwide.

Source: Samsung Bioepis

Ranbaxy launches first Biosimilar Infliximab in India!

Ranbaxy Laboratories Limited (Ranbaxy), one of India’s largest pharmaceutical company, announced on 1.12.2014 the launch of Infimab (BOW015), the first Remicade (infliximab) biosimilar in India.

Infimab, is being introduced in the Indian market through a licensing partnership with Epirus Biopharmaceuticals, Inc. a US and Swiss-based biopharmaceutical company focused on the global development and commercialization of biosimilar monoclonal antibodies. Infimab will be manufactured by Reliance Life Sciences at a facility in Mumbai. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis.

Infimab marks Ranbaxy’s entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Source: Ranbaxy press release

First Infliximab Biosimilar registered in India

EPIRUS Biopharmaceuticals, Inc. announced that it has received final marketing and manufacturing approvals for its Remicade (infliximab) biosimilar, BOW015, from the Drug Controller General of India (DCGI). BOW015 is the first infliximab biosimilar approved in India.

BOW015 is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. BOW015 will be manufactured by Reliance Life Sciences at a facility in Mumbai which was inspected and approved in July of this year. The DCGI has issued the final clearances for BOW015, and EPIRUS and its commercialization partner Ranbaxy Laboratories Limited (Ranbaxy) expect to launch the drug, under the brand name Infimab®, by the first quarter of 2015.

Ranbaxy and EPIRUS signed a licensing agreement for BOW015 in January of 2014. Under the terms of the agreement, EPIRUS will develop and supply BOW015, and Ranbaxy will register and commercialize BOW015 in India as well as in other territories in Southeast Asia, North Africa, and selected other markets.

 

FDA Accepts Sandoz Application for Biosimilar Filgrastim

Sandoz, a Novartis Group company, has announced that FDA has accepted its Biologics Licence Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

The reference product — Amgen’s Neupogen — is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.

“This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality,” said Mark McCamish, MD, PhD, and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. “As they’ve done in Europe and other highly regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system.”

Under the brand name Zarzio, the Sandoz biosimilar filgrastim has been marketed in more than 40 countries outside the US, generating nearly six million patient-exposure days of experience. Zarzio is the number one biosimilar filgrastim globally and is the leading daily G-CSF in Europe with 30% volume market share.

Source: Biopharma News

 

Consensus Document On Biosimilar Medicines Paper Is Now Available In Five Languages

Brussels, 25 June 2014 – After its successful launch in May 2013, the European Consensus Information Paper What you need to know about Biosimilar Medicinal Products is now available in English, French, German, Italian, Spanish and later this summer, Portuguese. This important comprehensive paper is a result of a co-operation of all relevant European stakeholders. It provides a clear and unbiased view of biosimilar medicines and how they are contributing to healthcare in Europe. It was elaborated in the context of the European Commission’s Process on Corporate Responsibility in

the Field of Pharmaceuticals and specifically the platform “Access to Medicines in Europe”, which focused on a number of topics including biosimilar medicines. This collaboration has since continued in order to make this multi-stakeholder paper accessible for patients, healthcare professionals, scientific societies and competent authorities in more languages. The involvement of industry, patient representatives, clinicians and national payers and the Commission ensured that these translations remain faithful to the original document. The Consensus Information Paper What you need to know about Biosimilar Medicinal Products is available in English, French, German, Italian and Spanish here, together with the other deliverables of the Project Group on Market Access and Uptake of Biosimilars. Source: EGA Press release

Falsified / stolen pharmaceutical products circulate in Germany!

German authorities are investigating currently the incidence of falsified / stolen Biopharmaceutical products originating from Italy. According to a BKA spokesperson six products are under scrutiny – Avastin, Mabthera, Herceptin, Remicade, Alimta and Humatrope. End of April EMA already warned about falsified Herceptin circulating on the german market. Obviously the Herceptin was stolen from italian hospitals and were sold via a UK wholesaler to german PI companies. The concerned batches were recalled from the german market. Rumor has it that 2 truckloads were stolen from Roche in Italy during transportation last December. Why the concerned batches were not recalled instantly is not known yet. There is a high risk that due to improper transporation temperature the quality of these goods may have been negatively impacted before they may have reentered to supply chain. On May 29th the warehouse of the pharma-forwarder “trans-o-flex” in Neuss was burgled. The thieves took 53 pharmaceuticals of Eurim Pharm, Johnson & Johnson, McNeil, MSD SHARP & DOHME, Bayer Vital, Janssen Cilag, CC Pharma and others. The list of stolen articles becomes longer day by day. Actuals List per 12.6.2014 of stolen products and batches can be found here (German only) – click on the red text and a PDF should open – batches are listed page 3 ff. The German “Arzneimittelkommission” advises to check the incoming goods since May 29th of the affected batches and deeply check them for any hints of manipulation.

Biocad’s biosimilar rituximab receives approval in Russia

The rituximab biosimilar which will be marketed under the trade name AcellBia, is the first mAb biosimilar to receive positive opinion from the Russian regulatory body.

The Russian MoH’s positive opinion on AcellBia is based on the results of randomized multicenter clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and efficacy of BCD-020 (rituximab biosimilar by BIOCAD) to the innovator rituximab. The registration clinical study of rituximab biosimilar in CD20-positive indolent non-Hodgkin’s lymphoma patients started in Russia in the end of 2011, and by mid-2012 it already involved over thirty centers in Russia, Ukraine, India, and South African Republic.

BIOCAD started work on rituximab biosimilar in 2010 in the context of a federal innovative project that was approved by the Presidential Commission on Modernization and Technological Advancement. The scope of the project included in-house development of mAb manufacturing technology, comprehensive characterization of developed biosimilars, comparative non-clinical and clinical studies.

The approval of AcellBia is definitely good news for patients who previously had limited access to advanced therapeutics, and in particular for those hindered by the extra high cost of antibody biopharmaceuticals. BIOCAD’s founder expressed hope that domestic capacity for production of high-quality, high-value biosimilars for treating diseases with the most profound social impacts will not only make the drugs more affordable, but will also help make the Russian healthcare sector less dependent on foreign imports.

BIOCAD’s rituximab biosimilar is produced in a special economic development district outside of St. Petersburg. BIOCAD is also finishing clinical trials of two more mAb biosimilars, bevacizumab and trastuzumab (biosimilars of Herceptin and Avastin by Hoffmann-La Roche), that will be produced at the same facility. The company has ten more mAb-based biosimilar and original products in the pipeline.

Source: BIOCAD press release

EUDRA GMDP DATABASE

GMDP Database showing Certificates, Licenses and Non-Compliance. EudraGMP is the database of the European Community of manufacturing authorisations and of certificates of good manufacturing practice. The EudraGMP system was launched in April 2007, for use by European Medicines Regulators. General public access via Internet is available since 2009. Information can be found about: MIA – Manufacturing and import authorizations GMP – Good Manufacturing Practice (GMP) certificates. GMP – Statements of non-compliance with GMP EudraGMDP – D is the new part regarding DISTRIBUTION – is the new name for the Union database since 2013. In addition the following new information are available: WDA – Wholesale Distribution Authorizations GDP – Good Distribution Certificates GDP – Statements of non-compliance with GDP API – Registration of manufacturers, importers and distributors of active substances for human use located in the EEA All GMP and GDP certificatesare listed in a database by the European Medicine Agency and all GMP and GDP authorities in Europe should enter the GMP and GDP certificates via an interface into this EMA database. It’s not complete yet, but it’s growing: Nearly 700 GDP certificates have been recently added in the EudraGMDP, and also two GDP-non-compliance-reports have been published yet – on 19.02.2014 + 27.03.2014 , both by the Czech authority. There the important information wghile using that database may not be forgotten: The absence of a GDP/GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GDP/GMP. e.g.: Germany has not entered any data yet – not one single German WDA or GDP certificate can be found. Anyhow Medizone is full compliant to GDP (https://medizone.com/wp-content/uploads/2013/09/Medizone_GDP_Certificate_17062013_gc.pdf ) and of course holding a valid WDA (https://medizone.com/wp-content/uploads/2013/01/Medizone_Gro%C3%9Fhandelslizenz.pdf) The database can be accessed via http://eudragmdp.ema.europa.eu Also a list of the National Competent Authorities (NCA) of the EEA can be found: http://eudragmdp.ema.europa.eu/inspections/viewCompetentAuthorityAddresses.do

EC published QUESTIONS AND ANSWERS to the GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE

The EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Health systems and Medicinal products – quality, safety and efficacy Has published additional information to the GDP 2013/C 343/01 GOOD DISTRIBUTION PRACTICE FOR MEDICINAL PRODUCTS

FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 1.0 The documents sets out frequently-asked ‘questions and answers’ regarding the new guidelines on Good Distribution Practice of medicinal products for human applicable as of 8 September 2013, and their revision of November 2013. It can be found http://ec.europa.eu/health/files/gdp/2014-04_qas_.pdf

Medizone and PassionBio agree on closer cooperation

PassionBio’s provides drug development, regulatory and commercial solutions for biologics, biosimilar/-better or mAb programs. Our aim is to foster cross-frontier development of your biosimilar portfolio. We support you with (pre-)clinical trial design and with your interactions with EU regulatory authorities. We help you select the right CRO and negotiate competitive budgets with CROs and other contractors in Europe. For more information please refer to our corporate site on PassionBio LinkedIn or

visit www.passionbio.at