Regulatory
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April 16th 2025
To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
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In the Effort to Develop Global Comparator Products, Biosimilars Lead the Way
February 1st 2019Biosimilars are often described as lagging behind generic drugs because there are fewer in the market and they have lower acceptance and uptake. However, according to stakeholders who spoke during the second day of the Medicines for Europe 18th Regulatory and Scientific Affairs Conference, held January 31 to February 1 in London, United Kingdom, biosimilars are leading the way in the effort to create global comparator products for use in drug development.
Innovent Seeks Chinese Regulatory Approval for Proposed Biosimilar Bevacizumab
January 30th 2019Innovent Biologics, a China-based biopharmaceutical company, recently submitted a New Drug Application for its proposed bevacizumab biosimilar, IBI-305, referencing Avastin, to the Chinese regulatory agency, the National Medical Products Administration.
Is It Time for a Global Reference Product for Biosimilars?
January 26th 2019On the last day of the 14th Biosimilars Summit, held January 22-23, 2019, in Alexandria, Virginia, the head of the FDA practice at Avalere discussed her point of view that enabling a global reference product for biosimilars would provide global access for patients.
EU Draws Closer to Adopting SPC Manufacturing Waivers for Biosimilars and Generics
January 20th 2019The European Union has announced that The Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) agreed this week on the European Council’s draft regulation that grants an exception to Supplementary Protection Certificates (SPCs).
New Paper Seeks to Clarify the US Position on Interchangeability
January 18th 2019A new paper, published this week in Current Medical Research and Opinion, seeks to clarify the US definition of interchangeability and differentiate it from the separate concepts of automatic substitution and physician-mediated switching.
As No-Deal Brexit Becomes More Likely, Drug Makers Warn of "Immediate Threat" to Patients
January 17th 2019After the UK Parliament voted to reject Prime Minister Theresa May’s proposed Brexit deal with just weeks to go before the United Kingdom’s planned withdrawal from the European Union, the pharmaceutical industry has warned that a no-deal Brexit poses “tangible and immediate threats” to patient safety and public health.
Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents
January 12th 2019Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars.
Celltrion Says Its Biosimilar Has Gained 56% of the European Infliximab Market
January 11th 2019Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.
Hospital Group Making Generic Drugs Adds 12 Additional Members
January 11th 2019Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.
FDA's Scott Gottlieb, MD, Highlights Biosimilars Initiatives in J.P. Morgan Keynote Address
January 9th 2019During the 37th annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California, FDA Commissioner Scott Gottlieb, MD, delivered a keynote address encompassing his goals for the direction of the FDA in the coming year.
New No-Deal Brexit Guidance Holds Changes for Biosimilars
January 6th 2019This week, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued updated guidance for industry on preparing for the growing likelihood that the United Kingdom will leave the European Union without a trade deal.
Stakeholders Weigh In on the Key Biosimilar Developments of 2018
December 31st 20182018 was an eventful year for the biosimilars marketplace. We asked experts from across stakeholder groups—and from the United States and abroad—what they felt were the most notable moments in biosimilars during 2018, and what they hope the new year holds for this developing industry.
Eye on Pharma: Chong Kun Dang's Darbepoetin Alfa Biosimilar Approved
December 24th 2018This month, Korean biosimilar developer Chong Kun Dang announced that it has received approval to sell its biosimilar, CKD-11101, referencing darbepoetin alfa (Aranesp). CKD-11101 is the first biosimilar of the erythropoiesis-stimulating protein to be authorized in a highly regulated nation.
GAO Finds Trouble With Orphan Drug Designations
December 24th 2018Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.
