JD Supra European Union › Goodwin

• JD Supra European Union

At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung...

• JD Supra European Union

On 15 January, 2021, the European Data Protection Board (“EDPB”) and the European Data Protection Supervisor (“EDPS”) adopted a joint opinion (“Joint Opinion”) on the draft new sets of Standard Contractual Clauses (“New SCCs”) for international transfers released by the European Commission in November 2020. The EDPB and the EDPS welcome the New SCCs but ask for clarity in some key areas,...

• JD Supra European Union

As part of the EU’s strategy on climate change following the Paris Agreement of 2015, a number of EU regulations have been enacted in the past 12 months. From the fund management industry’s point of view, the two most important are the “Sustainable Finance Disclosure Regulation” and the “Taxonomy Regulation.” The Taxonomy Regulation seeks to establish a classification system in...

• JD Supra European Union

Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical unit of the European Commission and EMA and was the Director responsible for all medical product-related regulatory activities at the WHO in Geneva from 2016 to November 2020

• JD Supra European Union

On October 29, 2020, the European Patent Office ruled in favor of Sanofi and Regeneron in their dispute concerning Amgen’s Praluent® (alirocumab) patent.  The EPO found invalid certain claims of Amgen’s European patent, EP 2 215 124, which is directed to PCSK9 antibodies.

• JD Supra European Union

Last week, the EMA issued a positive opinion for Orphan Drug Designation (“ODD”) to Prestige BioPharma’s PBP1510, a first-in-class anti-PAUF monoclonal antibody. PAUF is found in a majority of pancreatic cancers and plays an important role in disease progression; PBP1510 received ODD for the treatment of pancreatic cancer, for which there is not yet an approved targeted molecular therapy.

• JD Supra European Union

Today, Samsung Bioepis and Biogen announced that the EMA has accepted for review its Marketing Authorization for their proposed biosimilar product referencing eye disease product Lucentis (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.

• JD Supra European Union

On July 23, 2020, Centus Biotherapeutics received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for EQUIDACENT, a biosimilar to AVASTIN (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal...

• JD Supra European Union

Today (July 16) Europe’s highest court, the Court of Justice of the European Union (CJEU), in the case of Data Protection Commissioner v Facebook Ireland and Maximillian Schrems (Schrems II) invalidated the EU–U.S. Privacy Shield (Privacy Shield). The Court ruled that the Privacy Shield failed to offer adequate protections for EU personal data transferred to the U.S. The ruling is a stunning...

• JD Supra European Union

Last week, Lupin and Mylan announced that the European Commission had granted marketing authorization for their biosimilar Nepexto (etanercept) for all indications of the reference product. The marketing authorization follows a positive opinion from the Committee for Medicinal Products for Human Use earlier this year based on preclinical and clinical studies demonstrating bioequivalence to the...

• JD Supra European Union

The current economic, environmental and political outlook globally is perhaps the most uncertain it has been in decades. Against this backdrop, contracts are likely to be analysed and tested in ways unlike before. With this in mind, understanding the approach that the English courts will take in interpreting contracts and the legal principles that may be available to parties looking for options...

• JD Supra European Union

On April 30, 2020, Sanofi received a positive opinion from the European Medicines Agency (EMA)’s Committee for Medical Products for Human Use (CHMP), recommending the granting of marketing authorization for its biosimilar of insulin aspart (NovoRapid, marketed by Novo Nordisk).

• JD Supra European Union

Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the EU. The Xplore trial, which was started in 2019, is intended

• JD Supra European Union

Various measures have been implemented in Luxembourg to help Luxembourg funds tackle the impact of the COVID-19 outbreak... This is a fast-moving crisis and it is important to closely monitor the outbreak, its business impact and how it may affect the governance and performance of Luxembourg funds. As a result, the CSSF has taken the practical step to request any manager (whether or...

• JD Supra European Union

We previously reported that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP). In particular, the EMA reported that these applications were withdrawn after the agency had evaluated the company’s responses to EMA’s questions.

• JD Supra European Union

The European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP) recently reported biosimilar updates from its March 2020 meeting. At the meeting, Mylan and Lupin’s NEPEXTO (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing...

• JD Supra European Union

On 25 March 2020, the Luxembourg Government adopted a draft bill introducing new defensive measures denying the tax deduction of interest and royalty payments made to a related entity located in a blacklisted jurisdiction. This draft bill comes at a time when the Cayman Islands was added in February to the EU list of non-cooperative jurisdictions for tax purposes. These upcoming...

• JD Supra European Union

The Korean Herald reported today that Celltrion has applied for the European Medicine Agency’s approval of CT-P17, a Humira (adaliumumab) biosimilar.  According to the Korean Herald, Celltrion “expects to introduce CT-P17 to the European market in about a year’s time, which is how long the EMA typically takes to review.”

• JD Supra European Union

The Advocate General has issued an Opinion which states that the European Commission’s decision, enforcing the Standard Contractual Clauses (SCCs), is valid.

• JD Supra European Union

The European Court of Justice recently limited the “right to be forgotten” in a landmark decision for online privacy law. The decision arises from a dispute between Commission nationale de l'informatique et des libertés (CNIL) – the French data protection authority – and Google concerning the scope of the right to be forgotten. The right allows individuals to ask search engines to remove links...

• JD Supra European Union

Pfizer announced today that the European Commission has approved its Avastin® (bevacizumab) biosimilar ZIRABEV™ for the treatment of...

• JD Supra European Union

On February 5, 2019, Mundipharma announced the European launch of Pelmeg® (pegfilgrastim), a biosimilar of Neulasta®. As we have previously reported, Mundipharma acquired Pelmeg® from Cinfa Biotech and it was approved by the European Commission in November 2018.

• JD Supra European Union

The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report notes that, by monitoring the pharmaceutical market to ensure that price competition for pharmaceuticals is not artificially reduced or eliminated, and that anti-competitive...

• JD Supra European Union

The European Union's Directive 2015/849, better known as the 4th Anti-Money Laundering Directive, regulates prevention of the use of the financial system for the purposes of money laundering or terrorist financing. As such, Articles 30 and 31 of the 4th Anti-Money Laundering Directive introduce the requirement for each member state to establish beneficial ownership registers.

• JD Supra European Union

Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several adalimumab biosimilars launched in Europe this year.

• JD Supra European Union

On November 16, 2018, the European Data Protection Board (Board) (comprised of EU member state data protection authorities), published draft guidelines on the territorial scope of the GDPR (Guidelines).The Guidelines provide interpretive comments with illustrative use cases and are open for public consultation until January 18, 2019. Following public consultation, the Board is expected to issue...

• JD Supra European Union

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg?®, a product it had acquired from biosimilar development company Cinfa Biotech.

• JD Supra European Union

Amgen, Sandoz, Samsung and Mylan all launched adalimumab biosimilars in Europe this past October. On October 16, 2018, Amgen has announced that its adalimumab biosimilar AMGEVITA launched in European markets.

• JD Supra European Union

Amgen has announced that its adalimumab biosimilar AMGEVITA launched yesterday in European markets. This is Amgen’s first “inflammation” biosimilar to launch in Europe, and its second biosimilar to launch in Europe overall.

• JD Supra European Union

In August, we reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the granting of marketing authorization for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio® (adalimumab), a proposed biosimilar of Humira®; (2) Accord Healthcare’s Pelgraz® (pegfilgrastim), a proposed biosimilar of...