News & Analysis as of

European Medicines Agency (EMA)

Mylan Partners with Fujifilm Kyowa Kirin Biologics

by Goodwin on

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the...more

Brexit at Halfway: Pharma and Medical Devices

by WilmerHale on

The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more

Update on Biosimilar Launches and Development

by Goodwin on

Biocon announced yesterday that it has received marketing authorization approval from the European Commission for Semglee™ (insulin glargine). The decision came after receiving a positive recommendation by the Committee for...more

UK Parliamentary Committee Publishes Life Sciences Brexit Negotiation Recommendations

by Hogan Lovells on

The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. ...more

Amgen/Allergan & Sandoz Receive Positive CHMP Opinions

by Goodwin on

Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing...more

EMA’s pre-authorisation procedural advice for the centralised procedure updated

by Hogan Lovells on

The European Medicines Agency (“EMA”) has published an updated version of the guidance document on pre-authorisation for users of the centralised procedure. The update relates to a new question concerning the preparation of...more

Tell me your name and I'll tell you… if you comply with the French Health Authority's recommendations!

by Hogan Lovells on

On 22 February 2018, the French Health Authority (ANSM) published on its website its "Recommendations to applicants and holders of marketing and registration authorisations" on the names of medicines....more

EU Court ruling on how off-label use is to be analysed under competition law

by White & Case LLP on

On 23 January 2018, the Grand Chamber of the Court of Justice ("ECJ") delivered its judgment on preliminary reference from the Italian State Council in the Roche case, which concerns the off-label use of Avastin for the...more

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

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