Pipeline Report · 2021. 1. 10. · Pipeline Report oeber Pipeline Report November 2020. Recent...

© 2020 AcariaHealth. All rights reserved.

Pipeline ReportNovember 2020


Recent Drug Approvals 1

Upcoming Products 6

Biosimilars 14

Generic Specialty Agents 15

Table of ContentsThis quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, 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:

> 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 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 <likely> Regeneron’s 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% 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].

© 2020 AcariaHealth. All rights reserved. Page 1


Recent Drug Approvals

Continued

Drug Name Manufacturer(s) Indication(s)FDA Approval Date

AcariaHealth (AH) Access Status

Comments Cost (WAC)

ENDOCRINOLOGY

Sogroya somapacitan-beco subcutaneous injection

• NovoNordisk• Growth hormone

deficiency (GHD)8/28/20 Pending launch

• Approved for the treatment of adults.

• Once weekly dosing.

• Estimated prevalence of adult GHD: 2-3 per 10,000 people.

• Projected impact: cost replacement of existing therapies.

Pending launch

INFECTIOUS DISEASES

Inzameb atoltivimab, maftivimab, odesivimab-ebgn intravenous infusion

• Regeneron• Zaire ebolavirus

infection10/14/20 Pending launch

• For the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection.

• Projected impact: cost increase.

Pending launch

Veklury remdesivir intravenous infusion

• Gilead• Coronavirus

disease 2019 (COVID-19)

10/22/20 Limited access

• Approved for adults and pediatric patients (≥ 12 years of age and weighing ≥ 40 kg) requiring hospitalization due to COVID-19.

• Projected impact: cost increase.

$3,120/5-day course of therapy $5,720/10-day course of therapy



Continued




Comments Cost (WAC)

LY-CoV555 bamlanivimab intravenous infusion

• Eli Lilly • COVID-19 11/9/20 Limited access

• 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. Note: an EUA is not the same as full FDA approval.

• Eli Lilly will ship the first 300,000 doses of bamlanivimab to AmerisourceBergen, which will 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

The U.S. government will cover the cost of the first 300,000 bamlanivimab doses.

Olumiant baricitinib oral tablets

• Eli Lilly • COVID-19 11/19/20 AH has access

• 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 adults and pediatric patients 2 years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Note: an EUA is not the same as full FDA approval.

• Under the EUA, inpatient pharmacies in the U.S. may order Olumiant through Lilly authorized specialty distributors. A current list of Lilly's authorized distributors of record for the EUA is available at lillytrade.com.

Age 2-8 years: $1,057/14-day course of therapy

Age 9 years and older: $2,114/14-day course of therapy



Continued




Comments Cost (WAC)

MUSCULOSKELETAL CONDITIONS

Evrysdi risdiplam oral solution

• PTC Therapeutics

• Roche• Spinal muscular

atrophy (SMA)8/7/20 Limited access

• Approved for the treatment of SMA Types 1, 2, and 3.

• Is the first daily oral therapy approved for SMA.

• Will compete with Spinraza and Zolgensma.

• Projected impact: incremental cost increase.

$100,000 - $340,000/year

Viltepso viltolarsen intravenous infusion

• NS Pharma• Duchenne

muscular dystrophy (DMD)

8/12/20 Pending launch

• Exon 53 skipping agent.

• Antisense oligonucleotide.

• For the treatment of DMD amenable to exon 53-skipping.

• Will compete with Vyondys 53.

• Projected impact: cost replacement of existing therapy.

$733,000/year

NEUROLOGY

Kesimpta ofatumumab intravenous infusion

• Novartis• Multiple sclerosis

(MS)8/20/20 AH has access

• For the treatment of adults with relapsing forms of MS.

• Will compete with multiple other approved agents for clinically isolated syndrome and relapsing remitting disease.

• Will compete with Ocrevus and Mayzent for secondary progressive disease.


Year 1: $103,000 Year 2 and beyond: $83,000/year






Comments Cost (WAC)

ONCOLOGY

Blenrep belantamab mafodotin-blmf intravenous infusion

• GlaxoSmithKline • Multiple myeloma 8/5/20 Limited access

• For patients who have failed at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

• Approved with a Black Box Warning re: ocular toxicity.


$281,000/year

Onureg azacitidine oral tablets

• Bristol-Myers Squibb• Acute myeloid

leukemia (AML)9/1/20 AH has access

• Approved for continued treatment of adults who achieved first complete remission or complete remission with incomplete blood count recovery following intensive induction chemotherapy and are not able to complete intensive curative therapy.

• Oral dosing allows for extended drug exposure during each treatment cycle to prolong therapeutic activity.


$254,000/year

Gavreto pralsetinib oral capsules

• BluePrint Medicines• Non-small cell lung

cancer (NSCLC)9/4/20 Limited access

• Approved for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive NSCLC.

• Will compete with Retevmo for RET-positive NSCLC.

• Projected impact: cost replacement of existing therapy.

$234,000/year






Comments Cost (WAC)

OPHTHALMOLOGY

Enspryng satralizumab-mwge subcutaneous injection

• Genentech• Neuromyelitis

optica spectrum disorder (NMOSD)

8/14/20 AH has access

• Approved for use in AQP4 antibody-positive patients.

• Administered as a monthly subcutaneous injection after an initial loading phase.

• Soliris and Uplizna are also FDA-approved.


Year 1: $205,000 Year 2 and beyond: $175,000/year



Upcoming Products

Continued

* Expected to cost >$500,000 per member.

Drug Name Manufacturer(s) Indication(s) Mechanism of Action(s) CommentsAnticipated Approval Date

CARDIOVASCULAR

inclisiran subcutaneous injection

• Novartis • Hypercholesterolemia• Proprotein convertase

subtilisin/kexin type 9 (PCSK9) synthesis inhibitor

• Administered in the doctor’s office as twice yearly dosing.

• Would compete with the PCSK9 binding inhibitors for high cardiovascular risk patients who are already on maximized statin therapy.

12/1/20

REGN1500 evinacumab intravenous infusion

• Regeneron• Homozygous familial

hypercholesterolemia (HoFH)

• Anti-ANGPTL3 monoclonal antibody

• Administered as monthly intravenous infusions.

• Repatha, Juxtapid, and Kynamro are also FDA-approved for HoFH.

• Intended for use as adjunctive therapy to other agents, including PCSK9 inhibitors.

2/11/21

Revascor rexlemestrocel-L intramyocardial injection

• Mesoblast • Chronic heart failure • Stem cell therapy

• Potentially large impacted population.

• Proposed for use in left ventricular systolic dysfunction.

• Would be reserved for use in patients who had failed multiple other therapies.

2021

COAGULATION DISORDERS

Ryplazim plasminogen intravenous infusion

• Liminal BioSciences

• Congenital plasminogen deficiency (C-PLGD)

• Endogenous plasminogen analog

• There are currently no approved therapies for the treatment of C-PLGD, the estimated prevalence of which is ~1.6 of every 1,000,000 people.

3/5/21

AMT-061* etranacogene dezaparvovec intravenous infusion

• Uniqure • Hemophilia B • Gene therapy

• Proposed for the treatment of adults with severe disease (~40% of the total hemophilia B population).

• Current standard of care is factor IX replacement therapy.

2021

SPK-8011* intravenous infusion

• Spark

• Roche• Hemophilia A • Gene therapy

• Proposed for the treatment of adults with severe disease (~60% of the total hemophilia A population).

• Current standard of care is factor VIII replacement therapy or Hemlibra.

2021



Continued


Upcoming Products


SB-525* giroctocogene fitelparvovec intravenous infusion

• Sangamo BioSciences

• Inc/Pfizer• Hemophilia A • Gene therapy

• Proposed for the treatment of adults with severe disease (~60% of the total hemophilia A population).

• Current standard of care is factor VIII replacement therapy or Hemlibra.

2021-2022

DERMATOLOGY

CAT354 tralokinumab subcutaneous injection

• Leo Pharma • Atopic dermatitis • IL-13 inhibitor • Would compete with Dupixent for this indication. Q2 2021

ENDOCRINOLOGY

Zokinvy lonafarnib oral therapy

• Merck

• Eiger Biopharma

• Hutchinson‐Gilford Progeria Syndrome (HGPS)

• Progeroid laminopathies

• Farnesyltransferase inhibitor

• Progeria is an ultra-rare and fatal disease that causes premature aging in children.

• There are currently no FDA approved therapies.11/20/20

RM-493* setmelanotide subcutaneous injection

• Rhythm Pharmaceuticals

• Pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity

• Melanocortin agonist

• POMC and LEPR deficiency obesities are ultra-rare disorders.

• There are approximately 100 to 500 patients in the U.S. with POMC deficiency obesity and approximately 500 to 2,000 patients in the U.S. with LEPR deficiency obesity.

• There are no approved therapies for these two conditions.

11/27/20

ALN-GO1 lumasiran subcutaneous injection

• Alnylam• Primary hyperoxaluria

Type 1 (PH1)• RNAi therapeutic (gene

silencing)

• Administered as monthly injections.

• Current treatment options for advanced disease are very limited, and include frequent renal dialysis or combined organ transplantation of liver and kidneys.

• Although some patients respond to Vitamin B6 supplementation, there are no approved pharmaceutical therapies for PH1.

12/3/20



Continued


Upcoming Products


Orladeyo* berotralstat oral capsules

• BioCryst• Hereditary angioedema

(HAE)• Selective inhibitor of

plasma kallikrein

• Once daily oral therapy.

• All other HAE therapies are IV or SC injections.

• High demand for this more convenient, less invasive dosage form is anticipated.

• Estimated prevalence of HAE: 1 in 50,000 people.

12/3/20

PRX-102 pegunigalsidase alfa intravenous infusion

• Protalix Biotherapeutics

• Enzyme replacement therapy

• Fabry disease

• Fabrazyme, dosed once every two weeks, is also FDA-approved for the treatment of Fabry disease.

• PRX-102 is being studied as once monthly dosing as well as once every two weeks.

• Estimated prevalence: 1 in 40,000 to 60,000 males (female prevalence is unknown).

1/27/21

BRX345 arimoclomol oral therapy

• Orphazyme• Niemann-Pick type C

disease (NPC)• Molecular chaperone

activator

• There are no FDA-approved therapies for type C Niemann-Pick Disease, which has an estimated 500 cases diagnosed worldwide, and which affects ~1 in 120,000 newborns.

3/17/21

BBP-870 fosdenopterin intravenous infusion

• BridgeBio Pharma• Molybdenum cofactor

deficiency (MoCD) Type A

• cPMP substrate replacement therapy

• There are no FDA-approved therapies for MoCD Type A, an ultra-rare condition due to an inborn error of metabolism.

• Infants are most affected, with rapid disease progression and a high infant mortality rate.

3/29/21

HEMATOLOGY

FG-4592 roxadustat oral therapy

• AstraZeneca

• Fibrogen• Anemia of chronic

kidney disease

• Hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI)

• Proposed for use in both dialysis- and non-dialysis-dependent CKD.

• Would compete with erythropoietin stimulating agents (ESAs, e.g., Procrit, Aranesp).

• Appears to have less cardiovascular risk.

12/20/20

G1T28 trilaciclib intravenous infusion

• G1 Therapeutics

• Boehringer Ingelheim

• Cyclin dependent kinases (CDK4/CDK6) inhibitor

• Myelopreservation during cancer therapy

• Proposed for use in patients with small cell lung cancer receiving treatment with chemotherapy.

2/15/21



Continued


CCX168 avacopan oral therapy

• ChemoCentryx• C5a complement

protein receptor inhibitor

• Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV)

• Current therapies for ANCA-associated vasculitis typically include broad immunosuppression with daily doses of glucocorticoids such as prednisone or methylprednisone.

7/7/21

LentiGlobin* betibeglogene autotemcel intravenous infusion

• bluebird bio• Transfusion-dependent

beta-thalassemia (TDT)• Gene therapy

• Demonstrated ability to dramatically decrease or terminate the need for chronic blood transfusions.

2021

IMMUNOLOGY

BIVV009* sutimlimab intravenous infusion

• Sanofi• Cold agglutinin disease

(CAD)• Complement pathway

inhibitor

• Proposed for the treatment of hemolysis in patients with primary CAD.

• Rituxan is used off-label for this indication.11/13/20

Luveniq voclosporin oral capsule

• Aurinia • Lupus nephritis • Calcineurin inhibitor• Voclosporin is a structural analog of cyclosporine A,

developed to potentially offer a number of advantages over legacy calcineurin inhibitors.

1/22/21

INFECTIOUS DISEASES

REGN-COV2 intravenous infusion

• Regeneron• Coronavirus disease

2019 (COVID-19)• Anti-SARS-CoV2

monoclonal antibody

• 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 demonstrated a reduction in COVID-19–related 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.

For EUA: Q4 2020

MUSCULOSKELETAL CONDITIONS

Amondys 45* casimersen intravenous infusion

• Sarepta Therapeutics

• Duchenne muscular dystrophy (DMD)

• Antisense oligonucleotide• Proposed for the treatment of patients with mutations

amenable to exon 45 skipping.2/25/21


Upcoming Products



Continued

Upcoming Products


GALGT2* AAVrh74.MHCK.GALGT2 intra-arterial injection

• Sarepta• Duchenne muscular

dystrophy• Gene therapy

• Would compete with SRP-9001 gene therapy for those with mutations between exons 18 and 58.

• SRP-9001 is further along in the pipeline process, but it’s too early to distinguish between the two agents’ relative safety and efficacy profiles.

2021

SRP-9001* microdystrophin intravenous infusion

• Sarepta• Duchenne muscular


• Targets exons 18 through 58 (~60-75% of DMD patients have mutations in these exons).

2021

SGT-001* intravenous infusion

• Solid Biosciences• Duchenne muscular


• Development has been marred by safety issues and FDA-applied clinical trial holds, with thus far mediocre efficacy results.

2021-2022

NEUROLOGY

BIIB 037 aducanumab intravenous infusion

• Biogen

• Eisai• Alzheimer’s disease

• Amyloid-binding monoclonal antibody

• Proposed as a treatment for prodromal or mild stages of Alzheimer’s disease.

• In November, an FDA Advisory Committee voted against FDA approval of aducanumab. The FDA is not required to follow the advice of its Advisory Committees but often does, leaving uncertain the prospects for FDA approval of this agent.

3/7/21

RG3477 ponesimod oral therapy

• Janssen • Multiple sclerosis (MS)• Selective sphingosine-1-

phosphate receptor 1 (S1P1) modulator

• Proposed for treatment of relapsing forms of MS. Will compete with other S1P1 modulators such as Gilenya, Mayzent and Zeposia.

• Estimated prevalence: 1 million people in the United States.

• Relapsing MS is the most common form of MS, affecting ~85% of patients.

3/18/21




Continued

Upcoming Products


Lenti-D* elivaldogene tavalentivec intravenous infusion

• bluebird bio• Cerebral

adrenoleukodystrophy (cALD)

• Gene therapy

• Currently, the only therapeutic option for patients with cALD is allogeneic hematopoietic stem cell transplant (HSCT).

• Beneficial effect has been reported if performed early in the course of cALD progression.

• 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.

Q4 2021

ONCOLOGY

JCAR017 lisocabtagene maraleucel intravenous infusion

• Juno Therapeutics

• Non-Hodgkin’s lymphoma

• Chimeric antigen receptor T-cell (CART) therapy

• Would be third to market after Kymriah and Yescarta for this indication.

• Has demonstrated a relatively favorable adverse effect profile.

Q4 2021

Danyelza naxitamab intravenous infusion

• YmAbs Therapeutics, Inc.

• Neuroblastoma• Anti-GD2 3F8 monoclonal

antibody

• Proposed for the treatment of high risk neuroblastoma refractory to initial therapy or with incomplete response to salvage therapy in patients older than 12 months of age with persistent, refractory disease limited to bone marrow with or without evidence of concurrent bone involvement.

11/30/20

MGAH22 margetuximab intravenous infusion

• MacroGenics • Breast cancer• Anti-HER2 monoclonal

antibody

• Proposed for the treatment of HER2-positive metastatic disease, in combination with chemotherapy.

• Same mechanism of action as Herceptin.

12/18/20

TAK385 relugolix oral tablet

• Myovant • Prostate cancer • GnRH receptor antagonist

• Would compete with injectable GnRH analog therapies such as Lupron.

• Estimated prevalence: 3.2 million men in the United States.

12/20/20

Rolontis eflapegrastim subcutaneous injection

• Spectrum Pharmaceuticals

• Chemotherapy-induced neutropenia

• Colony stimulating factor

• Long-acting agent dosed every 3 weeks.

• Demonstrated non-inferiority to Neulasta.

• Is currently being studied with dosing on the same day as chemotherapy.

Q4 2020




Continued

Upcoming Products


TSR-042 dostarlimab intravenous infusion

• Tesaro

• GlaxoSmithKline• Endometrial cancer

• Anti-PD-1 monoclonal antibody

• Proposed for the treatment of recurrent or advanced disease that has progressed on or after a platinum-based regimen, including microsatellite instability high tumors.

Q4 2020

TGR-1202 umbralisib oral therapy

• TG Therapeutics• Marginal zone

lymphoma (MZL)• PI3K-delta and CK1-epsilon

inhibitor

• Similar indication as Imbruvica.

• Estimated prevalence: MZL accounts for approximately 8% of all non-Hodgkin lymphoma cases.

• ~15-30% of patients relapse and require rescue therapy.

2/15/21

EMD1214063 tepotinib oral therapy

• Merck

• EMD Serono• Non-small cell lung

cancer (NSCLC)• MET inhibitor

• Same indication as Tabrecta.

• Proposed for the treatment of advanced or metastatic disease with MET exon 14 skipping alterations.

• Estimated prevalence: 84% of all lung cancer cases are NSCLC.

• MET exon 14 skipping alterations and MET amplifications are present in 3-4% of NSCLC patients and correlate with poor prognosis.

2/25/21

p1101 ropeginterferon alfa-2b subcutaneous injection

• PharmaEssentia Corporation

• Polycythemia vera (PV)• Monopegylated proline

interferon

• Long-acting interferon formulation proposed for the treatment of PV in the absence of symptomatic splenomegaly.

3/15/21

bb2121 idecabtagene vicleucel intravenous infusion

• bluebird bio

• Bristol-Myers Squibb

• Multiple myeloma• B-cell maturation antigen

(BCMA)-targeted CAR-T cell therapy

• Similar proposed indication as, but apparently less robust efficacy than, JNJ-68284528, which demonstrated a 100% overall response rate in the CARTITUDE-1 trial.

3/27/21

Tivopath tivozanib oral therapy

• AVEO Oncology • Renal cell carcinoma• Multi-kinase inhibitor; triple

VEGF inhibitor

• Proposed for treatment of relapsed or refractory disease.

• Was more effective than Nexavar (sorafenib) in the TIVO-1 trial.

3/31/21




Upcoming Products


Lonca loncastuximab tesirine intravenous infusion

• ADC Therapeutics

• Diffuse large B-cell lymphoma (DLBCL)

• Antibody-drug conjugate containing anti-CD19 monoclonal antibody

• Similar CD19-targeted mechanism of action as Monjuvi (tafasitamab-cxix), which is also FDA-approved for use in relapsed/refractory DLBCL.

Q2 2021

JNJ-68284528 ciltacabtagene autoleucel intravenous infusion

• Janssen • Multiple myeloma • Anti-BCMA CAR-T therapy

• Proposed for the treatment of relapsed/refractory disease after at least three prior lines of therapy.

• Demonstrated a 100% overall response rate in the Phase I/II CARTITUDE-1 trial.

2021

Controlled IL-12* Ad-RTS-hIL-12/ veledimex intratumoral injection + oral therapy

• Ziopharm Oncology

• Recurrent glioblastoma• Gene therapy and oral

activator agent

• Current standard of care is surgery, followed by radiation and chemotherapy (usually with temozolomide).

• Would potentially be used after resection and radiation+temozolomide if progression or recurrence.

2021-2022

OPHTHALMOLOGY

NSR-REP1* subretinal injection

• Nightstar • Choroideremia • Gene therapy• Confirmation of diagnosis will be key, as clinical

presentation of this disease is similar to other conditions.

2021




Biosimilars

Drug Name Manufacturer(s)Biosimilar Reference Drug

Indication(s)Status/Estimated Approval

Biosimilar Currently Launched?

Comments

ENDOCRINOLOGY

MYL-1601D insulin aspart subcutaneous injection

• Mylan

• BioconNovolog • Diabetes mellitus

BLA is under FDA review (BsUFA date: 2Q2021)

No

• First biosimilar application after reclassification of insulin products as biologic agents.

IMMUNOLOGY

ABP 798 rituximab intravenous infusion

• Amgen

• AllerganRituxan • Rheumatoid arthritis

BLA is under FDA review (BsUFA date: 12/19/2020)

Yes - Ruxience, Truxima• Another biosimilar to

Rituxan, after Ruxience and Truxima.

ONCOLOGY

SB8 bevacizumab intravenous infusion

• Samsung Bioepis

• MerckAvastin • Breast cancer

BLA is under FDA review (BsUFA date: 4Q2020)

Yes - Mvasi, Zirabev• Another biosimilar to

Avastin, after Mvasi and Zirabev.

MYL-0401O bevacizumab intravenous infusion

• Mylan

• BioconAvastin • Breast cancer

BLA is under FDA review (BsUFA date: 12/27/2020)

Yes - Mvasi, Zirabev• Another biosimilar to

Avastin, after Mvasi and Zirabev.

MSB11455 pegfilgrastim subcutaneous injection

• Fresenius Kabi Neulasta • NeutropeniaBLA is under FDA review (BsUFA date: 3/27/21)

Yes - Fulphila

• Another biosimilar to Neulasta, after Fulphila, Nyvepria, Udenyca and Ziextenzo.



Generic Specialty Agents

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 fumarate

Symfi, Symfi Lo • Laurus Labs 8/27/20

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 fumarate

Atripla • Teva 10/2/20

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

asenapine Saphris

• Alembic (Tentative)

• Sigmapharm Laboratories (Tentative)

• Breckenridge

• Hikma

12/10/2020

abiraterone acetate Zytiga (500 mg) • Teva 2020

sunitinib Sutent • Mylan 8/16/21

thalidomide Thalomid• Hikma

• Lannett2021

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Pipeline Report · 2021. 1. 10. · Pipeline Report oeber Pipeline Report November 2020. Recent...

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