News & Analysis as of

European Medicines Agency (EMA)

eCTD Format Required for all Mutual Recognition Procedure Submissions

by Hogan Lovells on

Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”)....more

Year in Review: Top 5 Foreign Market Developments in 2017

by Goodwin on

Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017...more

2017 Biosimilar Approvals in Europe

The European biosimilar market has expanded at record pace in 2017.  The EMA approved marketing of sixteen biosimilar products referencing seven different innovator biologic products.  For five of the innovator products –...more

EMA released Practical Guidance for Brexit and Market Authorisation Holders

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”) will be required to take should the United Kingdom (“UK”) become a third...more

CHMP Adopts Positive Opinion for Celltrion’s Herzuma

by Goodwin on

On December 16, Celltrion announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Herzuma, its trastuzumab biosimilar. The...more

Fresenius Kabi Announces Submission of Application for Biosimilar of Humira (Adalimumab)

by Goodwin on

Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar regulatory filing....more

EMA provides essential considerations to be taken into account for successful qualification of novel methodologies

by Hogan Lovells on

The European Medicines Agency (“EMA”) has published a checklist of the essential considerations to be addressed for successful qualification of novel methodologies....more

Sandoz Announces Phase I Data For Its Pegfilgrastim Biosimilar

by Goodwin on

On December 8, 2017, Sandoz, a division of Novartis, announced data purportedly showing that its pegfilgrastim biosimilar candidate matches the reference biologic, Neulasta® in terms of pharmacokinetics, pharmacodynamics,...more

EMA published an assessors’ guidance document in connection with explanatory note to GVP module VII

by Hogan Lovells on

The European Medicines Agency (“EMA”) has released a guidance document for assessors. The guidance document is written in a questions-and-answers form. It should be read in combination with the explanatory note to GVP module...more

EMA launched improved version of EudraVigilance

by Hogan Lovells on

The European Medicines Agency (“EMA”) has launched a new and improved version of EudraVigilance. EudraVigilance is the system for managing and analysing information concerning suspected adverse reactions to medicinal products...more

EMA Accepts Applications for Two Mylan and Biocon Biosimilars

by Goodwin on

On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported, Biocon had earlier requested...more

UK publishes paper on Brexit and medicines regulation

by Hogan Lovells on

On the same day as the European Council voted to move the European Medicines Agency (EMA) from London to Amsterdam, the UK Parliament issued a briefing paper on Brexit and medicines regulation. ...more

EMAmsterdam: Hogan Lovells welcomes its new neighbour

by Hogan Lovells on

By Hein van den Bos, Ruth Franken and Silvia Gardini After months of discussion, a final vote has been cast on the European Medicines Agency (EMA)'s new home post-Brexit. And it's right around the corner from us, here in...more

European Medicines Agency heads for Amsterdam

by Allen & Overy LLP on

Today the 27 member states of the European Union have decided on Amsterdam as the new home of the European Medicines Agency. The decision came after three rounds of voting, with Amsterdam eventually emerging the winner after...more

New rules for expanded access in Italy

by Hogan Lovells on

Fast track for orphan diseases and rare forms of cancers - By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more

Boehringer Ingelheim’s First Biosimilar Is Approved in Europe

by Goodwin on

Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®. Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in...more

Biosimilars Update: Amgen, Allergan, Pfenex, Cinfa

by Goodwin on

Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more

Mylan Resubmits EMA Applications for Trastuzumab and Pegfilgrastim

by Goodwin on

As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency...more

Updates on Sandoz’s Pegfilgrastim Biosimilar / Amgen v. Sandoz

by Goodwin on

Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review. According to the press release, the data package submitted as part of...more

EMA senior officer: pharmaceutical companies encouraged to prepare for Brexit

by Hogan Lovells on

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a...more

EMA Accepts Application for Cinfa’s Pegfilgrastim Biosimilar

by Goodwin on

Last week, Cinfa Biotech S.L. announced that the European Medicines Agency (EMA) has accepted its application to market a molecule referred to as B12019, a biosimilar of Amgen’s Neulasta® (pegfilgrastim), for the treatment of...more

EMA publishes external guidance for clinical data publication

by Hogan Lovells on

On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use....more

The commission assessment – a decision-making aid for EMA's relocation?

by Hogan Lovells on

Last week, a staff retention survey was published, according to which certain contestants in the race for hosting the EMA were less liked by the EMA staff. And now the decision-making progress is going forward....more

EMA relocation - A public health crisis ahead?

by Hogan Lovells on

Blog Industries: Life Sciences and Healthcare By Dr. Tanja Eisenblätter EMA employees are taking precautions to avoid relocating to cities they consider less attractive, according to the results of a recent staff retention...more

EMA's reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

by Hogan Lovells on

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities....more

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