Articles by Anna Rose Welch

91. What To Know About Emerging Market Biosimilar Pathways 6/24/2016

    The emerging markets have been making strides in developing pathways for the approvals of biosimilars. However, there are several considerations companies need to keep in mind when putting together a dossier for market approval in Russia, Colombia, Peru, and Malaysia.  

92. BsUFA II: What Biosimilar Makers Need From FDA 6/7/2016

    The past few months, biosimilar makers, trade organizations, and the FDA have been hard at work on BsUFA reauthorization negotiations. Biosimilar makers’ needs have changed since BsUFA’s launch in 2012. The newest version of BsUFA is slowly being renegotiated in the hopes of better reflecting the current and future state of the changing biosimilar market.  

93. 4 Takeaways From The World Biosimilar Congress 5/25/2016

    Throughout this whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.

94. Navigating Brazil's Emerging Biosimilar Market 5/9/2016

    The Latin American markets, and especially Brazil, hold great promise for biosimilar development, PlantForm CEO Don Stewart says. In recent years, many partnerships have been launched in Brazil between local and international companies to bolster the country’s biosimilar development. However, there are a number of things companies looking to forge joint ventures in Brazil need to keep in mind for success.

95. “Growing” Biosimilars: How Plants Bolster Manufacturing Efficiency 5/2/2016

    Roughly 15 to 20 years ago, a number of pharmaceutical companies raised money to employ tobacco technology in drug development. Unfortunately, this rush did not lead to the success many were hoping for. However, the successes of recent players in this space suggest pharma could be entering a new age in plant-based manufacturing.

96. Will Medicare Part D Make Biosimilar Manufacturers Pay? 4/18/2016

    Despite biosimilars’ reputation as cheaper alternatives to costly biologics, Medicare Part D patients likely won’t see great savings — at least not right away. According to a recent Avelare Health report, there are two ways patients could see reduced biosimilar out-of-pocket costs. But one of these solutions could place a big burden on biosimilar manufacturers. 

97. Are Emerging U.S. Biosimilar Policies At Risk Of Alienating Physicians? 4/5/2016

    Educating physicians is a prime goal in the U.S. in order to ensure biosimilars are prescribed. However, are the U.S.'s emerging biosimilar policies already at risk of alienating physicians?

98. Is FDA Biosimilar Regulatory Process Defeating Purpose Of BPCIA? 3/29/2016

    The establishment of the BPCIA, at least conceptually, has been more efficient than the Hatch-Waxman Act, which established the approval pathway for small molecule generics. However, when it comes to developing the policies that will shape the biosimilar market, Dr. Bert Liang, CEO of biosimilar company Pfenex, says that the industry and the FDA are both at risk of defeating the purpose of the BPCIA.

99. What Does FDA's Biosimilar Workload Reveal About Emerging U.S. Market? 3/21/2016

    The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. regulatory landscape is unfolding.

100. Will China Emerge As A Biosimilar Development Hub? 3/7/2016

     As the global biosimilar market continues to grow, biotechs — small, medium, and large — are looking to biosimilars as a new and promising business opportunity. As Gerry McGettigan, COO of amp biosimilars AG (ampb), discusses, China offers a number of benefits for those building a biosimilar business.