Ninety per cent of US prescriptions volumes are generic drug products. Solid oral products constitute more than 75% of the generic drugs. The generic product development and commercialization incorporate complex process steps that need close portfolio management, alignment and monitoring. With increased regulatory actions, market insecurity and pricing pressures, generic organizations are required to apply evidence based new empirical approaches to product development and portfolio management. Watergile approach discussed in this article allows generic organizations to adapt, respond and evolve based on emerging conditions while delivering much needed affordable drug products to the end patient.
WillinghamE. Why did Mylan hike epipen process 400%? Because they could. Forbes, 2016.
3.
The Council of Economic Advisors. The administration’s FDA reforms and reduced biopharmaceutical drug prices, White House, 2018.
4.
SharplessN. Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs. FDA Statement, 2019.
5.
EbanK.Bottle of lies. New York, NY: Ecco Publishing, 2019.
6.
FDA. Drug supply chain security act (DSCA). US FDA, 2020.
7.
FDA. Orphan drug act – relevant excerpts. US FDA, 2013.
8.
MillerKLLanthierM.Investigating the landscape of US orphan product approvals. Orphanet J Rare Dis2018; 13.
9.
De la TorreBGAlbericioF.The pharmaceutical industry in 2018. An analysis of FDA drug approvals from the perspective of molecules. Molecules2019;
24: 809.
10.
FDA. Novel drug approvals for 2018. US FDA, 2019.
11.
McDermidB. Cigna rolls out new plan to fully cover multi-million dollar gene therapies. Reuters, (5 September 2019).
12.
GardnerJ.Medicines Co.’s cholesterol drug looks good to take on PCSK9 rivals. Washington, DC: Biopharma Dive, 2019.
13.
PagliaruloN.Novartis secures NICE nod for Luxturna with discount offer. Washington, DC: Biopharma Dive, 2019.
14.
MIT. Novartis-MIT Center for Continuous Manufacturing. MIT.EDU, Cambridge, MA, 2020.
15.
ISPE. 2017 ISPE facility of the year award winners announced. International Society for Pharmaceutical Engineering, 2017.
16.
CPI. CPI works with GSK and AstraZeneca on pharma manufacturing. UK-CPI, 2019.
17.
FDA. FDA approves pill with sensor that digitally tracks if patients have ingested their medication. US FDA, 2017.
