(accessed 20 September 2019).8 8 https://www.ppdi.com/drug‐registration‐china/home_fierce.htm; Ropes and Gray (2015). China: China Announces Final Biosimilars Guideline. https://www.ropesgray.com/news‐and‐insights/Insights/2015/March/China‐Announces‐Final‐Biosimilars‐Guideline.aspx?utm_source=Mondaq&utm_medium=syndication&utm_campaign=View‐Original (accessed 20 September 2019).
9 9 https://www.iqvia.com//media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf (accessed 20 September 2019).
10 10 https://www.phrma.org/advocacy/research‐development/biologics‐biosimilars; https://cdn.ymaws.com/www.casss.org/resource/resmgr/cmc_euro_speaker_slides/2018_cmce:JekerleVeronika.pdf (accessed 20 September 2019).
11 11 https://novel‐drugdelivery‐systems.pharmaceuticalconferences.com/events‐list/biologics‐biosimilars (accessed 20 September 2019).
12 12 https://www.prnewswire.com/news‐releases/commercialisation‐of‐biologics‐benchmarking‐leading‐players‐300563293.html (accessed 20 September 2019).
13 13 https://www.lifescienceleader.com/doc/the‐players‐in‐the‐biosimilar‐market‐archetypes‐0001; https://www.biosimilardevelopment.com/doc/biosimilar‐pipeline‐analysis‐market‐detailed‐industry‐report‐live‐covering‐players‐biocon‐pfizer‐0001; https://www.biopharmadive.com/news/7‐companies‐to‐know‐in‐the‐emerging‐biosimilars‐field/433539; https://www.mckinsey.com/industries/pharmaceuticals‐and‐medical‐products/our‐insights/five‐things‐to‐know‐about‐biosimilars‐right‐now (accessed 20 September 2019).
14 14 QI MIDAS Q4 2015, Pharmerging markets only – Pharmerging markets defined as a group of 21 emerging countries adding US$1 billion of cumulative pharmaceutical growth over the next five years.
15 15 https://www.marketwatch.com/press‐release/biologics‐market‐2019‐industry‐trends‐size‐growth‐insight‐share‐emerging‐technologies‐share‐competitive‐regional‐and‐global‐industry‐forecast‐to‐2024‐2019‐05‐24 (accessed 20 September 2019).
16 16 https://mordorintelligence.com:81/industry‐reports/biologics‐market (accessed 20 September 2019).
17 17 https://www.businesswire.com/news/home/20180831005463/en/Global‐Biologics‐Manufacturing‐Market‐2018‐2022‐Introduction‐New; https://www.iqvia.com/‐/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf (accessed 20 September 2019).
18 18 https://www.amgenbiotech.com/manufacturing‐innovation.html; https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life‐sciences‐health‐care/us‐lshc‐advanced‐biopharmaceutical‐manufacturing‐white‐paper‐051515.pdf; https://www.bio.live/visit/news‐and‐updates/biologics‐driving‐innovation‐drug‐packaging‐and‐devices (accessed 20 September 2019).
19 19 https://www.iqvia.com/‐/media/iqvia/pdfs/nemea/uk/disruption_and_maturity_the_next_phase_of_biologics.pdf; https://www.pharmaceutical‐journal.com/news‐and‐analysis/features/making‐drugs‐work‐better‐four‐new‐drug‐deliverynbspmethods/20203530.article?firstPass=false; https://fortune.com/2017/05/03/drug‐delivery‐breakthroughs (accessed 20 September 2019).
20 20 QuintilesIMS White paper: cell & gene therapies: innovation to commercialisation – can industry bridge the gap? Published QI 2015; FDA. Implementation of the Biologics Price Competition and Innovation Act of 2009. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm215089.htm (accessed 20 September 2019).
21 21 QI MIDAS Q4 2015, Pharmerging markets only – Pharmerging markets defined as a group of 21 emerging countries adding US$1 billion of cumulative pharmaceutical growth over the next five years.
22 22 FDA (2019). Considerations in Demonstrating Interchangeability with a Reference Product, Guidance (May 2019); FDA. From Our Perspective: Biosimilar Product Labeling. http://www.fda.gov/Drugs/NewsEvents/ucm493240.htm (accessed 20 September 2019).
23 23 https://www.mabxience.com/blogs/differences‐between‐substitution‐and‐interchangeability; https://www.biopharma‐reporter.com/Article/2017/03/21/Biosimilr‐switching‐interchangeability‐and‐substitution‐the‐EU‐view; https://safebiologics.org/wp‐content/uploads/2016/04/AUS‐Onepager‐Substitution‐FNLe.pdf; https://www.amgenbiosimilars.com/bioengage/prescribing‐biosimilars/substitution‐and‐interchangeability (accessed 20 September 2019).
24 24 https://www.mckinsey.com/industries/pharmaceuticals‐and‐medical‐products/our‐insights/whats‐next‐for‐biosimilars‐in‐emerging‐markets; https://www.beroeinc.com/whitepaper/biosimilars‐emerging‐markets (accessed 20 September 2019).
25 25 https://www.thebalance.com/top‐biologic‐drugs‐2663233 (accessed 20 September 2019); QI MIDAS Q4 2015, Pharmerging markets only – Pharmerging markets defined as a group of 21 emerging countries adding US$1 billion of cumulative pharmaceutical growth over the next five years.
3 Status of Biologic Drugs in Modern Therapeutics‐Targeted Therapies vs. Small Molecule Drugs
Cody Midlam
Willis Towers Watson, Cincinnati, OH, USA
KEY POINTS
Biologics are increasingly becoming the focus of pharmaceutical research and development.
Biologic medicines are able to treat certain diseases more efficiently than SMDs.
The cost of biologics is resulting in significant and potentially catastrophic strain on payer systems around the globe.
Orphan drugs will cost more than other drugs and the current development pipeline for these is relatively large.
Computer modeling techniques will generate an even higher probability of identifying biologic drug targets in the future.
Abbreviations
