Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle...more
On December 3, 2024, Bristol Myers Squibb announced a collaboration agreement with three-year-old startup AI Proteins. According to its founder, Chris Bahl, PhD, AI Proteins uses “AI, synthetic biology, and laboratory...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
It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs. See "Trump...more
President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more
JSR Life Sciences recently announced its launch of a new business division, “Similis Bio,” intended to help biosimilar drug developers “improve the efficiency and cost of biosimilar development.” Specifically, Similis Bio...more
In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more
After a turbulent year that roiled the economy, and the health care sector more than most, the Democrats emerged with control of both the White House and Congress for the first time since 2014. Business leaders and in-house...more
Earlier this week, Biogen and ViGeneron signed a global collaboration and licensing agreement to develop gene therapies for inherited eye diseases. The companies will use Munich-based ViGeneron’s proprietary adeno-associated...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more
It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more
Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more
On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world data (RWD): data that relates to patient...more
On September 10, 2018, Xbrane Biopharma announced that it has decided to shift its strategic focus of capital and resources toward biosimilars and away from its pipeline of generic long-acting injectables. In addition to...more
Mazumdar-Shaw, Chairman & Managing Director of Biocon, recently stated that Biocon is developing a portfolio of 10 biosimilars, and will continue to invest 12-15% of its revenue in research and development. According to Ms....more
On July 5, 2017, Daiichi Sankyo Company announced that it has decided to discontinue the development of CHS-0214, an investigational biosimilar to Amgen’s Enbrel® (etanercept), in Japan. Daiichi had been co-developing...more
BioCND, a South Korean biopharmaceutical company, announced on Monday that it will begin clinical development in Korea of ranibizumab, a biosimilar of Genentech’s Lucentis® injection for patients with wet age-related macular...more
As we previously reported, Amgen and Allergan are currently collaborating on four oncology biosimilars, including an Avastin® (bevacizumab) biosimilar, ABP 215. Yesterday, the companies announced the submission of a...more
We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more
Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
According to the Korea Pharmaceutical Manufacturers Association, the biosimilars market in South Korea will grow to 150 billion won (~$130 million) by 2019, nearly doubling in size from its 2013 value. Six biosimilars have...more
Biocon recently announced that its global phase III clinical development program for biosimilar insulin glargine “has crossed key interim milestones,” putting Biocon “on track for regulatory filings in US and EU in FY 17.” ...more