Page 166 - CW E-Magazine (29-10-2024)

Special Report Special Report

Bio/Pharma’s Top 10: Biologic-Based Drugs Regeneron Pharmaceuticals, the compa- lung cancer (NSCLC) market. The blood stem cells are transplanted back
nies’ eye-care drug, which makes the collaboration between AstraZeneca into the patient, where they engraft
high-dose version of Eylea poised for and Daiichi Sankyo combines Astra- (attach and multiply) within the bone
ow do biologic-based drugs over the last two years as measured by PATRICIA VAN ARNUM blockbuster status. Eylea is already a Zeneca’s strategic focus on NSCLC marrow and increase the production
rank among leading products new drug approvals by the US Food and blockbuster for the companies, but the and breast cancers and investment in of foetal haemoglobin (HbF), a type
Hof the top bio/pharma compa- Drug Administration’s Center for Drug Editorial Director, DCAT high-dose version is set to provide a ADCs with Daiichi Sankyo’s proprietary of haemoglobin that facilitates oxygen
nies? Which companies and products Evaluation and Research (CDER). status. Clarivate, a business intelli- defense against biosimilar competition DXd ADC technology. delivery. In patients with sickle-cell
are leading the pack? DCAT Value gence fi rm, in its 2024 Drugs To Watch for Eylea. The high-dose version of disease, increased levels of HbF pre-
Chain Insights takes an inside look. FDA’s CDER reviews and approves report, released earlier this year (2024), Eylea offers less-frequent administra- Altuviiio (efanesoctocog alfa) by vent the sickling of red blood cells.
new molecular entities and new biolo- identifi ed 13 new-to-market therapeu- tion for individuals with wet age-related Sanofi and Swedish Orphan Bio-
Biologic-based products on the rise gical therapeutics. Other biologic-based tics and drugs poised to launch in 2024 macular degeneration, diabetic macu- vitrum (Sobi) The FDA also approved in Decem-
Biologic-based products represent products, including blood products, that are projected to achieve blockbuster lar oedema, or diabetic retinopathy Efanesoctocog alfa is the fi rst once- ber 2023, bluebird bio’s Lyfgenia,
an important part of the commercial vaccines, allergenics, tissues, and cellu- status (defi ned as sales of $1-bn or whose treatment choices include inva- weekly factor VIII (FVIII) replacement another gene therapy for treating sickle-
portfolios of the top bio/pharmaceutical lar and gene therapies, are reviewed more) by 2029. Of these 13 products, sive, burdensome administration that intravenous infusion therapy, which cell disease. Lyfgenia uses a lentiviral
companies and overall in the industry. and approved by a separate center 10 are biologics, including biopharma- limits treatment uptake, according to will help reduce the burden associated vector (gene delivery vehicle) for
Of the top 10 selling products in 2023, within FDA, the Center for Biologics ceuticals, vaccines, and gene therapies. Clarivate. The high-dose afl ibercept with the injection frequency of other genetic modifi cation and is approved for
seven were biologics. These included: Evaluation and Research (CBER). The analysis includes candidates in offers less-frequent administration while currently available FVIII therapies. the treatment of patients 12 years of
Merck & Co.’s Keytruda (pembroli- Phase II or Phase III trials, at pre-regis- achieving similar effi cacy and safety as For patients reluctant to receive novel age and older with sickle-cell disease
zumab); AbbVie’s Humira (adalimu- In 2023, FDA’s CDER approved 17 tration or registration stage, or already the current standard of care. The high- therapies, such as monoclonal anti- and a history of vaso-occlusive events.
mab); Pfi zer’s/BioNTech’s Comirnaty new biological therapeutics, a recent launched in 2023, including both novel dose version of Eylea is expected to be bodies or gene therapy, efanesoctocog Exagamglogene autotemcel and lovotibe-
(COVID-19 vaccine mRNA); Bayer’s high, and representing 31% of new treatments and already-marketed drugs challenged by other agents currently alfa will likely be an appealing option, glogene autotemcel are set to become
and Regeneron Pharmaceuticals’ Eylea drug approvals by FDA’s CDER. In pursuing new indications that could be approved or in active late-phase deve- notes Clarivate. Clinicians also view the fi rst disease-modifying therapies
(afl ibercept); Sanofi ’s and Regene- 2022, 15 of the 37 new drug approvals particularly impactful. Drugs launched lopment, including Roche’s Vabysmo efanesoctocog alfa favourably given for sickle cell disease and beta-thalas-
ron Pharmaceuticals’ Dupixent (dupi- by FDA’s CDER were biologics, which prior to 2023 were excluded. Recently (faricimab), biosimilars of afl ibercept, the attainable FVIIII levels, injection semia, a blood disorder that reduces
lumab); Johnson & Johnson’s Stelara represented 41% of the new drug ap- launched and soon-to-launch therapeu- and Oculis’ pipeline candidate, OCS-01. frequency, and safety profi le demon- the production of haemoglobin, a signi-
(ustekinumab); and Bristol-Myers provals by FDA’s CDER, which was tics set to signifi cantly transform treat- strated in clinical trials to date. Sanofi fi cant achievement for a patient popula-
Squibb’s and Ono Pharmaceutical’s an increase over prior years. Between ment paradigms, even if they are not Datopotamab deruxtecan by Astra- has development and commercializa- tion that have limited symptomatic and
Opdivo (nivolumab). 2018 and 2021, biologic approvals by forecast to be blockbusters within fi ve Zeneca and Daiichi Sankyo tion rights for efanesoctocog alfa in the curative treatments currently available,
FDA’s CDER averaged 26% of new years, were included in the analysis. The antibody drug conjugate US, and Sobi is responsible for deve- according to Clarivate.
Depending on the market analysis drug approvals. In 2021, biologics rep- The leading blockbuster contenders in (ADC), datopotamab deruxtecan, by loping and marketing the drug in Europe
used, another seven biologics made resented 28% of new drug approvals, biologics are outlined below. AstraZeneca and Daiichi Sankyo is and other markets. Omvoh (mirikizumab) by Eli Lilly and
the top 20-selling drugs in 2023. These 25% in 2020, 21% in 2019, and 29% another biologic-based drug poised Company
included: Johnson & Johnson’s Darza- in 2018. High-dose Eylea (afl ibercept) by Bayer for blockbuster status. As an ADC, it Two gene therapies: Casgevy (exagam- Lilly’s Omvoh (mirikizumab), a
lex/Darzalex Faspro (daratumumab); and Regeneron Pharmaceuticals is composed of a small-molecule pay- glogene autotemcel) by Vertex Pharma- monoclonal antibody targeting the p19
Merck & Co.’s Gardasil/Gardasil 9 Biologics’ blockbuster potential Less-frequent administration is a load linked to a monoclonal antibody. ceuticals and CRISPR Therapeutics and subunit of IL-23, which plays a role
(human papillomavirus quadrivalent Several new biologic-based pro- key attribute of the high-dose version Specifi cally, it consists of a humanized Lyfgenia (lovotibeglogene autotemcel) in infl ammation related to ulcerative
(Types 6, 11, 16, and 18) vaccine, re- ducts are also projected for blockbuster of Eylea (afl ibercept) by Bayer & antitrophoblast cell-surface antigen 2 by bluebird bio colitis, was approved as a fi rst-in-class
combinant/human papillomavirus 9- (TROP2) monoclonal antibody linked Casgevy became the fi rst FDA- therapy for ulcerative colitis by the
valent vaccine, recombinant); AbbVie’s to a potent, exatecan-derived topoiso- approved treatment to use the genome- European Medicines Agency and the
Skyrizi (risankizumab-rzaa); Eli Lilly merase I inhibitor payload via a plasma- editing technology, CRISPR, with its FDA and will likely be the third in the
and Company’s Trulicity (dulaglutide); stable, selectively cleavable linker. It approval by the FDA in December class approved for Crohn’s disease.
Roche’s Ocrevus (ocrelizumab); Mod- is poised to compete against another 2023. Casgevy is a gene therapy for
erna’s Spikevax (COVID-19 vaccine ADC, Gilead Sciences’ Trodelvy (saci- treating sickle-cell disease in patients Two respiratory syncytial virus vaccines:
mRNA); and Pfi zer’s Prevnar (Pneu- tuzumab goviteca) as a Trop-2-directed 12 years and older. CRISPR/Cas9 is Arexvy by GlaxoSmithKline and Abrysvo
mococcal vaccine). antibody and topoisomerase inhibitor a type of genome-editing technology by Pfi zer
drug conjugate. under which patients’ hematopoietic Two vaccines for respiratory syncy-
New drug approvals: small molecules (blood) stem cells are modifi ed by tial virus (RSV) infections also make
versus biologics Datopotamab deruxtecan is set to genome editing. CRISPR/Cas9 can be the list of potential blockbusters. RSV
Although small-molecule drugs still be used for both HR-positive/HER2- directed to cut DNA in targeted areas, continue to be a public health concern,
dominate new drug approvals, the share negative and triple-negative breast enabling the ability to accurately edit particularly for infants and older adults
of biologic-based drugs has increased cancer and to enter the non-small cell DNA where it was cut. The modifi ed (65 years and older), according to the

166 Chemical Weekly October 29, 2024 Chemical Weekly October 29, 2024 167

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