Pipeline Report November 2020

© 2020 AcariaHealth. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs: Recent Drug Approvals 1 > On COVID-19, the FDA granted full approval to Veklury (remdesivir) for the treatment of COVID-19. Veklury is approved for use in hospitalized adults and pediatric patients (≥ 12 years of age and weighing ≥ 40 Upcoming Products 6 kg), and represents the very first therapy to garner full FDA approval for COVID-19. Other therapies will follow, gaining market access through EUA (LLY’s Bamlanivimab and Olumiant, and Regeneron’s Biosimilars 14 REGN-COV2). With the US crossing the 11 million total coronavirus infection mark, demand for these agents will be high while supply of the antibody treatment will be especially tight.

The vaccine race accelerates as there are now two m-RNA based candidates both showing greater than 94% Generic Specialty Agents 15 efficacy in study populations. Both vaccines require 2 doses. Neither has FDA approval, and EUA reviews are pending. Supplies will be limited for months to come. Pfizer has stated it could produce 50 million doses by the end of 2020, and Moderna has promised up to 20 million doses in the same time frame. During 2021 Pfizer forecasts 1.3 billion doses while Moderna states between 500 million and 1 billion. > Other therapies approved promise to expand and enhance patient options over currently available therapies, including Sogroya for growth hormone deficiency, Kesimpta for multiple sclerosis, and Enspryng for neuromyelitis optica spectrum disorder. > Looking forward, we are awaiting FDA action on several key pipeline agents that each represent first-time therapies for rare or ultra-rare conditions, including Hutchinson-Gilford Progeria syndrome, Niemann-Pick type C disease, genetically mediated obesity, and molybdenum cofactor deficiency type A. > Additionally, aducanumab is another potential new treatment for a much more common condition – mild or prodromal Alzheimer’s disease. Despite a recent FDA Advisory Committee vote against FDA approval, the FDA is not required to take the advice of the Committee, and as such there remains the possibility of FDA approval in light of the intense unmet need identified in the treatment armamentarium for Alzheimer’s disease.

To prepare this report, our team accesses a wide range of clinical resources. This information is then analyzed, resulting in updates across multiple disease states including recent and anticipated drug approvals, key changes in the biosimilar agent landscape, and notes on recent and anticipated generic product launches. Our pipeline report is just one of many ways we’re committed to providing helpful tools and resources to our clients and partners. We look forward to sharing more updates with you in the months ahead.

Ross Hoffman, MD

To provide comments, feedback or requests for report enhancements, please email us at [email protected]. Pipeline Report Recent Drug Approvals November 2020

FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date ENDOCRINOLOGY • Approved for the treatment of adults. Sogroya • Once weekly dosing. somapacitan-beco • Growth hormone • NovoNordisk 8/28/20 Pending launch • Estimated prevalence of adult GHD: 2-3 per Pending launch subcutaneous deficiency (GHD) 10,000 people. injection • Projected impact: cost replacement of existing therapies. INFECTIOUS DISEASES Inzameb • For the treatment of infection caused by Zaire atoltivimab, ebolavirus in adult and pediatric patients, • Zaire ebolavirus maftivimab, • Regeneron 10/14/20 Pending launch including neonates born to a mother who is RT- Pending launch infection odesivimab-ebgn PCR positive for Zaire ebolavirus infection. intravenous infusion • Projected impact: cost increase. $3,120/5-day • Approved for adults and pediatric patients (≥ course of Veklury • Coronavirus 12 years of age and weighing ≥ 40 kg) requiring therapy remdesivir • Gilead disease 2019 10/22/20 Limited access hospitalization due to COVID-19. intravenous infusion (COVID-19) $5,720/10- • Projected impact: cost increase. day course of therapy

FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date • An Emergency Use Authorization (EUA) was granted for the emergency treatment of mild to moderate disease in adults and pediatric patients with positive results of direct SARS- CoV-2 viral testing who are 12 years of age and older weighing ≥ 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. The U.S. Note: an EUA is not the same as full FDA government will LY-CoV555 approval. cover the cost of bamlanivimab • Eli Lilly • COVID-19 11/9/20 Limited access the first 300,000 intravenous infusion • Eli Lilly will ship the first 300,000 doses of bamlanivimab bamlanivimab to AmerisourceBergen, which will doses. distribute it as directed by the U.S. government's allocation program. Weekly allocation decisions will be proportionally based on confirmed COVID-19 cases in each state and territory over the previous seven days. • Projected impact: cost increase after U.S. government cost coverage ends • An EUA was granted for emergency use of Olumiant, in combination with remdesivir (Veklury), for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized Age 2-8 years: adults and pediatric patients 2 years of age or $1,057/14- older requiring supplemental oxygen, invasive day course of Olumiant mechanical ventilation, or extracorporeal therapy baricitinib • Eli Lilly • COVID-19 11/19/20 AH has access membrane oxygenation. oral tablets Note: an EUA is not the same as full FDA Age 9 years and approval. older: $2,114/14- • Under the EUA, inpatient pharmacies in the U.S. day course of may order Olumiant through Lilly authorized therapy specialty distributors. A current list of Lilly's authorized distributors of record for the EUA is available at lillytrade.com.

FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date MUSCULOSKELETAL CONDITIONS • Approved for the treatment of SMA Types 1, 2, and 3. Evrysdi • PTC Therapeutics • Spinal muscular $100,000 - risdiplam 8/7/20 Limited access • Is the first daily oral therapy approved for SMA. • Roche atrophy (SMA) $340,000/year oral solution • Will compete with Spinraza and Zolgensma. • Projected impact: incremental cost increase. • Exon 53 skipping agent. • Antisense oligonucleotide. Viltepso • Duchenne • For the treatment of DMD amenable to exon viltolarsen • NS Pharma muscular 8/12/20 Pending launch 53-skipping. $733,000/year intravenous infusion dystrophy (DMD) • Will compete with Vyondys 53. • Projected impact: cost replacement of existing therapy. NEUROLOGY • For the treatment of adults with relapsing forms of MS. • Will compete with multiple other approved Year 1: $103,000 Kesimpta agents for clinically isolated syndrome and • Multiple sclerosis ofatumumab • Novartis 8/20/20 AH has access relapsing remitting disease. Year 2 and (MS) intravenous infusion • Will compete with Ocrevus and Mayzent for beyond: secondary progressive disease. $83,000/year • Projected impact: cost replacement of existing therapies.

FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date ONCOLOGY • For patients who have failed at least four prior therapies including an anti-CD38 monoclonal Blenrep antibody, a proteasome inhibitor, and an belantamab immunomodulatory agent. • GlaxoSmithKline • Multiple myeloma 8/5/20 Limited access $281,000/year mafodotin-blmf • Approved with a Black Box Warning intravenous infusion re: ocular toxicity. • Projected impact: cost replacement of existing therapies. • Approved for continued treatment of adults who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and Onureg are not able to complete intensive • Acute myeloid azacitidine • Bristol-Myers Squibb 9/1/20 AH has access curative therapy. $254,000/year leukemia (AML) oral tablets • Oral dosing allows for extended drug exposure during each treatment cycle to prolong therapeutic activity. • Projected impact: cost replacement of existing therapies. • Approved for the treatment of adults with metastatic rearranged during transfection (RET) Gavreto fusion-positive NSCLC. • Non-small cell lung pralsetinib • BluePrint Medicines 9/4/20 Limited access • Will compete with Retevmo for RET-positive $234,000/year cancer (NSCLC) oral capsules NSCLC. • Projected impact: cost replacement of existing therapy.

FDA AcariaHealth (AH) Drug Name Manufacturer(s) Indication(s) Approval Comments Cost (WAC) Access Status Date OPHTHALMOLOGY • Approved for use in AQP4 antibody-positive patients. Year 1: $205,000 Enspryng • Neuromyelitis • Administered as a monthly subcutaneous satralizumab-mwge • Genentech optica spectrum 8/14/20 AH has access injection after an initial loading phase. Year 2 and subcutaneous disorder (NMOSD) beyond: injection • Soliris and Uplizna are also FDA-approved. $175,000/year • Projected impact: cost replacement of existing therapies.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date CARDIOVASCULAR • Administered in the doctor’s office as twice inclisiran • Proprotein convertase yearly dosing. subcutaneous • Novartis • Hypercholesterolemia subtilisin/kexin type 9 • Would compete with the PCSK9 binding inhibitors for 12/1/20 injection (PCSK9) synthesis inhibitor high cardiovascular risk patients who are already on maximized statin therapy. • Administered as monthly intravenous infusions. REGN1500 • Homozygous familial • Repatha, Juxtapid, and Kynamro are also FDA- • Anti-ANGPTL3 monoclonal evinacumab • Regeneron hypercholesterolemia approved for HoFH. 2/11/21 antibody intravenous infusion (HoFH) • Intended for use as adjunctive therapy to other agents, including PCSK9 inhibitors. • Potentially large impacted population. Revascor • Proposed for use in left ventricular systolic rexlemestrocel-L • Mesoblast • Chronic heart failure • Stem cell therapy dysfunction. 2021 intramyocardial injection • Would be reserved for use in patients who had failed multiple other therapies. COAGULATION DISORDERS Ryplazim • Congenital • There are currently no approved therapies for the • Liminal • Endogenous plasminogen plasminogen plasminogen deficiency treatment of C-PLGD, the estimated prevalence of 3/5/21 BioSciences analog intravenous infusion (C-PLGD) which is ~1.6 of every 1,000,000 people. AMT-061* • Proposed for the treatment of adults with severe etranacogene disease (~40% of the total hemophilia B population). • Uniqure • Hemophilia B • Gene therapy 2021 dezaparvovec • Current standard of care is factor IX replacement intravenous infusion therapy. • Proposed for the treatment of adults with severe SPK-8011* • Spark disease (~60% of the total hemophilia A population). • Hemophilia A • Gene therapy 2021 intravenous infusion • Roche • Current standard of care is factor VIII replacement therapy or Hemlibra. * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Proposed for the treatment of adults with severe SB-525* • Sangamo giroctocogene disease (~60% of the total hemophilia A population). BioSciences • Hemophilia A • Gene therapy 2021-2022 fitelparvovec • Current standard of care is factor VIII replacement • Inc/Pfizer intravenous infusion therapy or Hemlibra. DERMATOLOGY CAT354 tralokinumab • Leo Pharma • Atopic dermatitis • IL-13 inhibitor • Would compete with Dupixent for this indication. Q2 2021 subcutaneous injection ENDOCRINOLOGY • Hutchinson‐Gilford Zokinvy Progeria Syndrome • Progeria is an ultra-rare and fatal disease that causes • Merck • Farnesyltransferase lonafarnib (HGPS) premature aging in children. 11/20/20 • Eiger Biopharma inhibitor oral therapy • Progeroid • There are currently no FDA approved therapies. laminopathies • POMC and LEPR deficiency obesities are ultra-rare disorders. • Pro-opiomelanocortin RM-493* • There are approximately 100 to 500 patients in the (POMC) deficiency setmelanotide • Rhythm U.S. with POMC deficiency obesity and approximately obesity and leptin • Melanocortin agonist 11/27/20 subcutaneous Pharmaceuticals 500 to 2,000 patients in the U.S. with LEPR deficiency receptor (LEPR) injection obesity. deficiency obesity • There are no approved therapies for these two conditions. • Administered as monthly injections. • Current treatment options for advanced disease are ALN-GO1 very limited, and include frequent renal dialysis or lumasiran • Primary hyperoxaluria • RNAi therapeutic (gene • Alnylam combined organ transplantation of liver and kidneys. 12/3/20 subcutaneous Type 1 (PH1) silencing) injection • Although some patients respond to Vitamin B6 supplementation, there are no approved pharmaceutical therapies for PH1. * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Once daily oral therapy. Orladeyo* • All other HAE therapies are IV or SC injections. • Hereditary angioedema • Selective inhibitor of berotralstat • BioCryst 12/3/20 (HAE) plasma kallikrein • High demand for this more convenient, less invasive oral capsules dosage form is anticipated. • Estimated prevalence of HAE: 1 in 50,000 people. • Fabrazyme, dosed once every two weeks, is also FDA- approved for the treatment of Fabry disease. PRX-102 • Protalix • Enzyme replacement • PRX-102 is being studied as once monthly dosing as pegunigalsidase alfa • Fabry disease 1/27/21 Biotherapeutics therapy well as once every two weeks. intravenous infusion • Estimated prevalence: 1 in 40,000 to 60,000 males (female prevalence is unknown). • There are no FDA-approved therapies for type C BRX345 • Niemann-Pick type C • Molecular chaperone Niemann-Pick Disease, which has an estimated 500 arimoclomol • Orphazyme 3/17/21 disease (NPC) activator cases diagnosed worldwide, and which affects ~1 in oral therapy 120,000 newborns. • There are no FDA-approved therapies for MoCD Type BBP-870 • Molybdenum cofactor A, an ultra-rare condition due to an inborn error of • cPMP substrate fosdenopterin • BridgeBio Pharma deficiency (MoCD) metabolism. 3/29/21 replacement therapy intravenous infusion Type A • Infants are most affected, with rapid disease progression and a high infant mortality rate. HEMATOLOGY • Proposed for use in both dialysis- and non-dialysis- FG-4592 • Hypoxia-inducible factor dependent CKD. • AstraZeneca • Anemia of chronic roxadustat prolyl hydroxylase inhibitor • Would compete with erythropoietin stimulating 12/20/20 kidney disease oral therapy • Fibrogen (HIF-PHI) agents (ESAs, e.g., Procrit, Aranesp). • Appears to have less cardiovascular risk. G1T28 • G1 Therapeutics • Cyclin dependent • Myelopreservation during • Proposed for use in patients with small cell lung trilaciclib kinases (CDK4/CDK6) 2/15/21 • Boehringer cancer therapy cancer receiving treatment with chemotherapy. intravenous infusion Ingelheim inhibitor * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Anti-neutrophil • Current therapies for ANCA-associated vasculitis CCX168 • C5a complement cytoplasmic typically include broad immunosuppression with daily avacopan • ChemoCentryx protein receptor 7/7/21 antibody (ANCA)- doses of glucocorticoids such as prednisone oral therapy inhibitor associated vasculitis (AAV) or methylprednisone. LentiGlobin* betibeglogene • Transfusion-dependent • Demonstrated ability to dramatically decrease or • bluebird bio • Gene therapy 2021 autotemcel beta-thalassemia (TDT) terminate the need for chronic blood transfusions. intravenous infusion IMMUNOLOGY BIVV009* • Proposed for the treatment of hemolysis in patients • Cold agglutinin disease • Complement pathway sutimlimab • Sanofi with primary CAD. 11/13/20 (CAD) inhibitor intravenous infusion • Rituxan is used off-label for this indication. Luveniq • Voclosporin is a structural analog of cyclosporine A, voclosporin • Aurinia • Lupus nephritis • Calcineurin inhibitor developed to potentially offer a number of advantages 1/22/21 oral capsule over legacy calcineurin inhibitors. INFECTIOUS DISEASES • Currently under FDA review for issuance of an Emergency Use Authorization (EUA). Note: an EUA is not the same as full FDA approval • An interim analysis of an ongoing Phase 2/3 trial REGN-COV2 • Coronavirus disease • Anti-SARS-CoV2 • Regeneron demonstrated a reduction in COVID-19–related For EUA: Q4 2020 intravenous infusion 2019 (COVID-19) monoclonal antibody medical visits through Day 29 of 57%, and by 72% in patients with one or more risk factors. • It is anticipated that the U.S. government will supply the initial doses of REGN-COV2 after EUA approval. MUSCULOSKELETAL CONDITIONS Amondys 45* • Sarepta • Duchenne muscular • Proposed for the treatment of patients with mutations casimersen • Antisense oligonucleotide 2/25/21 Therapeutics dystrophy (DMD) amenable to exon 45 skipping. intravenous infusion * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Would compete with SRP-9001 gene therapy for those GALGT2* with mutations between exons 18 and 58. AAVrh74.MHCK. • Duchenne muscular • Sarepta • Gene therapy 2021 GALGT2 dystrophy • SRP-9001 is further along in the pipeline process, but intra-arterial injection it’s too early to distinguish between the two agents’ relative safety and efficacy profiles. SRP-9001* • Duchenne muscular • Targets exons 18 through 58 (~60-75% of DMD microdystrophin • Sarepta • Gene therapy 2021 dystrophy patients have mutations in these exons). intravenous infusion • Development has been marred by safety issues and SGT-001* • Duchenne muscular • Solid Biosciences • Gene therapy FDA-applied clinical trial holds, with thus far mediocre 2021-2022 intravenous infusion dystrophy efficacy results. NEUROLOGY • Proposed as a treatment for prodromal or mild stages of Alzheimer’s disease. BIIB 037 • Biogen • Amyloid-binding • In November, an FDA Advisory Committee voted aducanumab • Alzheimer’s disease against FDA approval of aducanumab. The FDA is 3/7/21 • Eisai monoclonal antibody intravenous infusion not required to follow the advice of its Advisory Committees but often does, leaving uncertain the prospects for FDA approval of this agent. • Proposed for treatment of relapsing forms of MS. Will compete with other S1P1 modulators such as Gilenya, RG3477 • Selective sphingosine-1- Mayzent and Zeposia. ponesimod • Janssen • Multiple sclerosis (MS) phosphate receptor 1 (S1P1) • Estimated prevalence: 1 million people in the 3/18/21 oral therapy modulator United States. • Relapsing MS is the most common form of MS, affecting ~85% of patients. * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Currently, the only therapeutic option for patients with cALD is allogeneic hematopoietic stem cell transplant (HSCT). Lenti-D* • Cerebral • Beneficial effect has been reported if performed early elivaldogene • bluebird bio adrenoleukodystrophy • Gene therapy in the course of cALD progression. Q4 2021 tavalentivec (cALD) intravenous infusion • In the U.S., newborn screening for ALD was added to the Recommended Universal Screening Panel in February 2016 and is currently active in 17 states, accounting for > 58% of U.S. newborns. ONCOLOGY JCAR017 • Would be third to market after Kymriah and Yescarta lisocabtagene • Juno • Non-Hodgkin’s • Chimeric antigen receptor for this indication. Q4 2021 maraleucel Therapeutics lymphoma T-cell (CART) therapy • Has demonstrated a relatively favorable adverse intravenous infusion effect profile. • Proposed for the treatment of high risk neuroblastoma refractory to initial therapy or with Danyelza • YmAbs • Anti-GD2 3F8 monoclonal incomplete response to salvage therapy in patients naxitamab Therapeutics, • Neuroblastoma 11/30/20 antibody older than 12 months of age with persistent, refractory intravenous infusion Inc. disease limited to bone marrow with or without evidence of concurrent bone involvement. • Proposed for the treatment of HER2-positive MGAH22 • Anti-HER2 monoclonal metastatic disease, in combination with margetuximab • MacroGenics • Breast cancer 12/18/20 antibody chemotherapy. intravenous infusion • Same mechanism of action as Herceptin. • Would compete with injectable GnRH analog TAK385 therapies such as Lupron. relugolix • Myovant • Prostate cancer • GnRH receptor antagonist 12/20/20 oral tablet • Estimated prevalence: 3.2 million men in the United States. Rolontis • Long-acting agent dosed every 3 weeks. eflapegrastim • Spectrum • Chemotherapy- • Demonstrated non-inferiority to Neulasta. • Colony stimulating factor Q4 2020 subcutaneous Pharmaceuticals induced neutropenia • Is currently being studied with dosing on the same injection day as chemotherapy. * Expected to cost >$500,000 per member. © 2020 AcariaHealth. All rights reserved. Continued Page 11 Pipeline Report Upcoming Products November 2020

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date • Proposed for the treatment of recurrent or advanced TSR-042 • Tesaro • Anti-PD-1 monoclonal disease that has progressed on or after a platinum- dostarlimab • Endometrial cancer Q4 2020 antibody based regimen, including microsatellite instability intravenous infusion • GlaxoSmithKline high tumors. • Similar indication as Imbruvica. • Estimated prevalence: MZL accounts for TGR-1202 • Marginal zone • PI3K-delta and CK1-epsilon approximately 8% of all non-Hodgkin lymphoma umbralisib • TG Therapeutics 2/15/21 lymphoma (MZL) inhibitor cases. oral therapy • ~15-30% of patients relapse and require rescue therapy. • Same indication as Tabrecta. • Proposed for the treatment of advanced or metastatic disease with MET exon 14 skipping alterations. EMD1214063 • Merck • Non-small cell lung tepotinib • MET inhibitor • Estimated prevalence: 84% of all lung cancer cases 2/25/21 cancer (NSCLC) oral therapy • EMD Serono are NSCLC. • MET exon 14 skipping alterations and MET amplifications are present in 3-4% of NSCLC patients and correlate with poor prognosis. p1101 ropeginterferon • Long-acting interferon formulation proposed for • PharmaEssentia • Monopegylated proline alfa-2b • Polycythemia vera (PV) the treatment of PV in the absence of symptomatic 3/15/21 Corporation interferon subcutaneous splenomegaly. injection bb2121 • Similar proposed indication as, but apparently • bluebird bio • B-cell maturation antigen idecabtagene less robust efficacy than, JNJ-68284528, which • Multiple myeloma (BCMA)-targeted CAR-T 3/27/21 vicleucel • Bristol-Myers demonstrated a 100% overall response rate in the cell therapy intravenous infusion Squibb CARTITUDE-1 trial. • Proposed for treatment of relapsed or refractory Tivopath • Multi-kinase inhibitor; triple disease. tivozanib • AVEO Oncology • Renal cell carcinoma 3/31/21 VEGF inhibitor oral therapy • Was more effective than Nexavar (sorafenib) in the TIVO-1 trial. * Expected to cost >$500,000 per member.

Anticipated Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) Comments Approval Date Lonca • Antibody-drug conjugate • Similar CD19-targeted mechanism of action as • ADC • Diffuse large B-cell loncastuximab tesirine containing anti-CD19 Monjuvi (tafasitamab-cxix), which is also FDA- Q2 2021 Therapeutics lymphoma (DLBCL) intravenous infusion monoclonal antibody approved for use in relapsed/refractory DLBCL. JNJ-68284528 • Proposed for the treatment of relapsed/refractory ciltacabtagene disease after at least three prior lines of therapy. • Janssen • Multiple myeloma • Anti-BCMA CAR-T therapy 2021 autoleucel • Demonstrated a 100% overall response rate in the intravenous infusion Phase I/II CARTITUDE-1 trial. Controlled IL-12* • Current standard of care is surgery, followed Ad-RTS-hIL-12/ by radiation and chemotherapy (usually with • Ziopharm • Gene therapy and oral veledimex • Recurrent glioblastoma temozolomide). 2021-2022 Oncology activator agent intratumoral injection • Would potentially be used after resection and + oral therapy radiation+temozolomide if progression or recurrence. OPHTHALMOLOGY • Confirmation of diagnosis will be key, as clinical NSR-REP1* • Nightstar • Choroideremia • Gene therapy presentation of this disease is similar to other 2021 subretinal injection conditions. * Expected to cost >$500,000 per member.

Biosimilar Reference Status/Estimated Biosimilar Currently Drug Name Manufacturer(s) Indication(s) Comments Drug Approval Launched? ENDOCRINOLOGY • First biosimilar application MYL-1601D • Mylan BLA is under FDA review after reclassification insulin aspart Novolog • Diabetes mellitus No (BsUFA date: 2Q2021) of insulin products as subcutaneous injection • Biocon biologic agents. IMMUNOLOGY ABP 798 • Amgen BLA is under FDA review • Another biosimilar to rituximab Rituxan • Rheumatoid arthritis (BsUFA date: Yes - Ruxience, Truxima Rituxan, after Ruxience intravenous infusion • Allergan 12/19/2020) and Truxima. ONCOLOGY SB8 • Another biosimilar to • Samsung Bioepis BLA is under FDA review bevacizumab Avastin • Breast cancer Yes - Mvasi, Zirabev Avastin, after Mvasi and (BsUFA date: 4Q2020) intravenous infusion • Merck Zirabev. MYL-0401O • Mylan BLA is under FDA review • Another biosimilar to bevacizumab Avastin • Breast cancer (BsUFA date: Yes - Mvasi, Zirabev Avastin, after Mvasi and intravenous infusion • Biocon 12/27/2020) Zirabev. • Another biosimilar to MSB11455 BLA is under FDA review Neulasta, after Fulphila, pegfilgrastim • Fresenius Kabi Neulasta • Neutropenia Yes - Fulphila (BsUFA date: 3/27/21) Nyvepria, Udenyca and subcutaneous injection Ziextenzo.

Recent Approvals GENERIC NAME BRAND NAME MANUFACTURER(S) MARKET LAUNCH DATE metyrosine Demser • Amneal 7/30/20 deferasirox Jadenu Sprinkle • Alkem Labs 8/5/20 dimethyl fumarate Tecfidera • Mylan 8/18/20 efavirenz/lamivudine/tenofovir disoproxil Symfi, Symfi Lo • Laurus Labs 8/27/20 fumarate emtricitabine Emtriva (capsules) • Cipla 9/1/20 tobramycin Bethkis • Teva 9/15/20 lapatinib ditosylate Tykerb • Natco Pharma 9/29/20 sapropterin dihydrochloride Kuvan (tablet and powder) • Par; Dr. Reddy's 10/1/20 efavirenz/emtricitabine/tenofovir disoproxil Atripla • Teva 10/2/20 fumarate emtricitabine/tenofovir disoproxil fumarate Truvada (200 mg/300 mg) • Teva 10/2/20 rufinamide Banzel oral suspension • Hikma 11/1/20 Pipeline Agents GENERIC NAME BRAND NAME MANUFACTURER(S) ANTICIPATED LAUNCH DATE • Alembic (Tentative) • Sigmapharm Laboratories (Tentative) asenapine Saphris 12/10/2020 • Breckenridge • Hikma abiraterone acetate Zytiga (500 mg) • Teva 2020 sunitinib Sutent • Mylan 8/16/21 • Hikma thalidomide Thalomid 2021 • Lannett

© 2020 AcariaHealth. All rights reserved. Page 15 AcariaHealth, an Envolve Pharmacy Solution, is a national comprehensive specialty pharmacy focused on improving care and outcomes for patients living with complex conditions, such as hepatitis C, multiple sclerosis, oncology, rheumatoid arthritis, hemophilia, cystic fibrosis and other conditions. Offering specialized care management services in these disease states, AcariaHealth is dedicated to enhancing the patient care offering, collaborating with providers and capturing relevant data to measure patient outcomes.

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