Articles by Anna Rose Welch

81. How To Prepare Your Biosimilar Company For Interchangeability 9/21/2016

    While attending a recent biosimilars conference, I heard few clear opinions about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward perspective.

82. 3 Lessons From The GPhA Biosimilars Council Conference 9/14/2016

    This inaugural conference touched upon many of the topics one would expect, including reimbursement, interchangeability, naming, the global markets, and IP challenges. But I felt three overarching topics were particularly worthy of being singled out.

83. Biobetters: How Much Competition Should Biosimilar Makers Expect? 8/1/2016

    In the last few weeks, news stories have surfaced reminding the biosimilar industry that biobetters are alive and, for the most part, well. Overall, there are upwards of 500 biobetters in development worldwide. But should the biosimilar industry really be concerned about biobetters quashing the use of biosimilars?

84. The Norwegian Biosimilar Phenomenon: From Biosimilar To “Biogeneric” 7/26/2016

    Following the recent Amgen and Sandoz FDA advisory committee meetings, which focused heavily on concerns about “non-medical switching,” Dr. Steiner Madsen’s often frank discussion on how switching contributed to biosimilar uptake in Norway provides reassurance and best practices for global biosimilar makers.

85. How “Consumer Reports” FDA Approvals Could Hurt Biosimilars 7/21/2016

    A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars. 

86. Amgen, Sandoz Biosimilar FDA AdComs: 5 Takeaways 7/18/2016

    Though both FDA advisory committees unanimously recommended approval and extrapolation of both Amgen's and Sandoz's biosimilars, this process was not as cut-and-dried as expected following the overwhelmingly positive FDA briefing documents. The stumbling points of each committee are important to note prior to your own candidates' FDA submission. 

87. Post-Brexit: The U.K. Biosimilar Market 7/13/2016

    In recent weeks, the U.K. made the seismic decision to leave the E.U. But biosimilars aren’t without support. Prior to Brexit, the U.K. celebrated the launch of the BBA, which has several initiatives underway to keep biosimilars a priority in the newly independent country.

88. Will Teva's Play Usher Generic, Biosimilar Makers Into “Innovator” Territory? 7/7/2016

    PhRMA is facing a controversial, potentially industry-altering decision. The generics king Teva has requested to become a member of the trade organization that traditionally represents “innovators”. Could this move redefine the industry's perception of "innovation"?

89. What Biosimilars Can Learn From The Diamond Industry 7/5/2016

    Not only are there some fascinating parallels between the fledging biosimilar and lab-grown diamond industries, but there are also some lessons biosimilar makers can take away from the development and commercialization of lab-grown diamonds.

90. 6 Tips For Navigating Emerging Market Biosimilar Regulations 6/29/2016

    In his presentation at the 2016 World Biosimilar Congress USA, Elliot Morales, senior director of regulatory affairs, at Dr. Reddy’s Laboratories, discussed the regulatory landscape for companies planning to introduce biosimilars in emerging markets. There were six points worth noting from this presentation which can alter the shape and timeline of a global development program and market approval.