SkadBytes Podcast | Tech’s Shifting Landscape: Five Trends Shaping the Conversation
Daily Compliance News: April 25, 2025, The Trouble in Travel Edition
Daily Compliance News: April 24, 2025, The Made in Malaysia Edition
Fierce Competition Podcast | Below-Threshold Mergers: Global Antitrust Scrutiny
Fierce Competition Podcast | Takeaways From the Illumina-Grail Merger Challenge Saga
The EU Corporate Sustainability Due Diligence Directive
The Informed Board Podcast | Will the EU’s Focus on Foreign Subsidies Make It More Difficult To Acquire European Businesses?
EU & UK Competition Law & Public Interest: Best Practices & New Challenges ahead
Nota Bene Episode 135: Europe Q3 Check In: Brexit, Data Protection, and Block Exemption Regulations with Oliver Heinisch
NGE On Demand: Personal Data Protection Travels: The New Standard Contractual Clause with John Koenigsknecht and David Wheeler
Nota Bene Episode 123: Europe Q2 Check In - Brexit Updates and Antitrust Laws in the Digital Economy with Oliver Heinisch
Nota Bene Episode 112: How Europe is Filling Enforcement Gaps for Digital Gatekeepers with Robert Klotz and Ciara Barbu-O’Connor
Nota Bene Episode 106: The Corporate Investor Movement Toward Environmental, Social, and Governmental Policies with Allison Troianos and Ariel Yehezkel
Nota Bene Episode 102: Examining European Union State Aid in the Face of COVID and Brexit with Jacques Derenne and Robert Klotz
What's Next after the Schrems II Decision of ECJ
Compliance Perspectives: The End of the Privacy Shield
Nota Bene Episode 89: European Q3 Check In - Merger Clearance and Data Protection Court Rulings and Brexit Updates with Oliver Heinisch
Podcast: ESMA Report: Undue Pressure on Companies
Nota Bene Episode 65: European Check In: Environmental Protection, Privacy Regulations, Digital Market Definition, and Brexit with Oliver Heinisch
Nota Bene Episode 55: Updates on the European Commission and Brexit with Isabelle Rahman and Oliver Heinisch
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more
On February 23, 2025, Celltrion announced that the European Commission (“EC”) approved its tocilizumab biosimilar, AVTOZMA® (CT-P47), referencing Roche’s ROACTEMRA®....more
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. ...more
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands....more
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab....more
On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as the (proposed) “EU Pharmaceutical Law...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s...more
The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe. As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or...more
On 11 March 2021, GCR hosted a series of interactive webinars. Our global co-head of antitrust, Elaine Johnston, participated in the panel that looked at the development of biologics and the role that antitrust has to play in...more
The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical...more
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...more
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
The European Commission recently announced a report on the impact of biosimilar competition on price, volume and market share, based on full-year data from 2016. The report, prepared by QuintilesIMS, analyzed six established...more