Hikma has eyes on launching a generic of Amarin’s Vascepa in the US following FDA approval and a favorable patent ruling at the district level in March. However, with a swift appeal filed by the originator in the works, the Jordanian firm is yet to pull the trigger.
Analysts remain skeptical that Hikma Pharmaceuticals will choose to launch ‘at-risk’ its generic Vascepa (icosapent ethyl) 1g capsules in the US, after the company announced receipt of US Food and Drug Administration approval.
In late March, Hikma, alongside Dr Reddy's Laboratories, received an order from a US district court in Nevada invalidating...
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
Avoiding disaster at the beginning of the pandemic and offering a pro-active supply chain blueprint should position the generics industry well for an onshoring debate in Congress, but a look back at March 2020 is a reminder that even small policy shifts can have a big impact.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Nichi-Iko says that remediation activities at its Toyama plant in the wake of a suspension over GMP violations mean that there may be delays to supply.
Teva and Biocon Biologics have become the latest firms to sign up to the Biosimilars Forum industry association in the US.
After US President Joe Biden launched a review of the country’s API supply chain, the task force has reported back with key vulnerabilities that contribute to drug shortages and supply risks during a global public health emergency. According to the report, the lack of geographic diversity and dependence on foreign nations and anti-competitive actions by foreign nations are key areas of concern.
Laboratorio Elea has struck a deal with Nichi-Iko Pharmaceutical to market the Japanese firm’s infliximab biosimilar in Argentina.
