[June 20, 2016]

World Generic Markets Issue Report - FDA Budget Request Takes Aim At Pay-For-Delay Agreements - Research and Markets

Research and Markets has announced the addition of the "World Generic Markets Issue 278 (V15 I11)" report to their offering.

The FDA budget request for FY17 again reveals proposals to reduce the data exclusivity period for biologics in order to promote biosimilar competition. This provision has been raised before, and implementation is as unlikely now as it has ever been. Proposals to prohibit pay-for-delay agreements are newer and suggest the FDA agrees with the FTC (News - Alert) on the issue. However, an FDA ban could lead to legal challenges.

Key Topics Covered:

1. Successful Integration And Restructuring Essential For Lannett's Future Prospects
2. Vensun Launches Caisoprodol Tablets
3. Aurobindo Gains Isosulfan Blue Approval
4. Lupin Launches Metformin
5. CMS Biosimilar Reimbursement Rule Highlights Need For Interchangeability Guidance
6. Promius Pharma Gains Betamethasone Spray Approval
7. Depomed Gains Favourable Markman Ruling In Tapentadol Litigation
8. Pfizer Edges Towards US Biosimilar Infliximab Dominance
9. Lannett Gains Temozolomide Approval
10. FDA Approves Impax' Mixed Amphetamines ANDA
11. Europe
12. EMA (News - Alert) Accepts Sandoz' Biosimilar Pegfilgrastim Submission
13. Biocon Gains EU Rosuvastatin Approval
14. MedinCell/Sandoz Collaborate To Develop Long-Acting Injectable Products
15. Meda Acquisition Will Expand Mylan's Product And Regional Outlook
16. JHL Gains European Rituximab Trial Approval
17. Battle Against TPP Far From Over
18. Africa/Middle East
19. Generics Remain Essential For Teva As Copaxone Revenues Falter

View source version on businesswire.com: http://www.businesswire.com/news/home/20160620005977/en/

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