This article summarizes the key provisions of the new law and discusses its limitations. I then look at the FTC’s practice in evaluating “reverse payment” settlements in Hatch-Waxman litigations and discuss why similar antitrust analyses of biosimilar settlements will likely be more complex.
Rather than focusing on whether the market has a solid basis to survive, one expert presents some interesting perspectives on the need for a more measured perspective on the market’s financial growth, as well as on the current role of biosimilar competition and differentiation.
During our conversation, Kokino and I walked through the steps Mylan took to establish this foundation, as well as how the company’s overseas biosimilar experiences influenced its global — including the U.S. — biosimilar launch strategy.
The proposed text of the U.S.–Mexico–Canada Agreement (USMCA) is intended to replace the North American Free Trade Agreement (NAFTA), which has been in place since the mid-1990s. There have been some very strong reactions. Is the USMCA “an important step in bringing Mexico and Canada closer to high U.S. standards” or a crushing blow to patients that will “stifle biosimilar competition"? As with most things, the details will matter, and of course the House and Senate must still approve the agreement. It’s important to consider 1) Whether the 10-year exclusivity impacts the filing of biosimilar applications, 2) What this change means in terms of the prioritization of some medicines from a public policy standpoint, and 3) The impact the agreement has on efforts to make biosimilars more accessible in the U.S.
Biopharmaceutical processes — and the technologies that enable them — have experienced remarkable progress in the past 30 years, since the first biopharmaceuticals were approved for human use. This article will highlight some of today’s top trends in bioprocessing, as this exciting field continues to flourish.
I reached out to several employer groups around the country to learn how each is approaching biosimilars with its members. I also wanted to find out what employers might need from biosimilar companies moving forward. Matt Harman of Employers Health shares his perspective on employers' excitement level over biosimilars and what knowledge they need most.
While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.
I reached out to Biosimilar Development editorial board member Molly Burich of Boehringer Ingelheim for her input on the policies she expects could have the largest positive or negative impact on biosimilars, as well as what progress has been made on the policy front.
With the continued policy dialogue on how rising drug costs impact patient access, the theoretical cost savings that biosimilars may offer is intriguing to many policymakers as well as those in the industry.
In the wake of the arrival of Humira biosimilars in the EU, Jorge Santos da Silva and Jennifer Heller of McKinsey & Company share several critical pricing and market considerations for companies as this highly anticipated product finally becomes available to patients.
The ultimate goal of the biopharmaceutical industry is to ensure a consistent supply of safe and effective drugs to patients who need them. One key factor in doing so is to address the challenges of raw material sourcing and management.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
Watch this video to learn more about this manufacturing site capabilities, quality management systems, PPI implementation, product expansion, assurance of supply and lead times.
By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, Industry 4.0 offers improved process reliability and product quality through unlimited possibilities of connecting machines and data.
Cory Card, Principal Scientist at GE, discusses not just ideas shared at a recent industry symposium on raw material variability control, but, most importantly, where to go from here.
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