REG - AstraZeneca PLC - Annual Financial Report <Origin Href="QuoteRef">AZN.L</Origin> - Part 8
08/03/2016 12:10
- Part 8: For the preceding part double click ID:nRSH4027Rg
required to provide copies of the biosimilar application or manufacturing
information but needed to provide 180-day commercial marketing notice to
the reference sponsor. Although this decision and other ongoing legal
challenges do not directly impact an AstraZeneca biologic, uncertainty
regarding the abbreviated biosimilar approval pathway may remain until
these initial legal challenges reach final conclusion.In Europe, the EMA
published final guidelines on similar biologics containing MAbs and in
May 2012, the first MAb biosimilar application was submitted with
recommendation for approval made by the EMA. Notably, various
jurisdictions have adopted either the EMA guidelines or those set forth
by WHO to enable biosimilars to enter the market after discrete periods
of data exclusivity.
- More to follow, for following part double click ID:nRSH4027RiRecent news on AstraZeneca
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