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Examples of recent advances by Indian firms in complex generics arena

Aurobindo has one ANDA pending for
1 approval and has filed four DMFs in the

peptide space.

Cadila Healthcare has five ANDAs pending 2

for approval in the transdermal space.

Biocon has two biosimilar filings pending for
3 approval each for US and EU market / filed

one glatriamoid.

Cipla has good mix of products pending and 4

under development in complex generics.

Lupin has filed ~2 ANDAs in inhalation segment, ~8 ANDAs
5 in ophthalmic, ~31 ANDAs in topical, and has a good number

of products under development in injectables

Biosimilars-Tackling the change in Disease Burden

Biologics are evolving as the standard of care to treat NCDs such as Diabetes and Breast Cancer. The global biologics market

accounts for 1/3rd of the pharma market; with the US representing the largest share. The biologics market is expected to
grow to US$ 650+ Bn by 2027. Biosimilars are affordable versions of biologics that can address the affordability and access

challenges while ensuring the same treatment outcomes. The global biosimilar market has grown to US$ 19 Bn (5x times in the

last 5 years) in 2022 and is expected to grow to US$ 56 Bn by 2027. There is an opportunity for the biosimilars market as more

than 55+ blockbuster drugs lose exclusivity by 2032.

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