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Home , Abrocitinib, Amivantamab, Anifrolumab, Infigratinib, Loncastuximab tesirine, Margetuximab

Specialty Pipeline MONTHLY UPDATE

Critical updates in an ever changing environment

June 2021

NEW DRUG INFORMATION

™ ● Rybrevant (-vmjw): The U.S. Food and Drug Administration (FDA) has granted the accelerated approval of Rybrevant (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung (NSCLC) with epidermal receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based . Rybrevant is the first fully-human, bispecific approved for the treatment of patients with NSCLC that targets EGFR exon 20 insertion mutations, which are the third most prevalent activating EGFR mutation. Patients newly diagnosed with metastatic NSCLC with EGFR exon 20 insertion mutations have a median overall survival (OS) of 16.2 months. Rybrevant was approved based on a Phase 1 study, CHRYSALIS, that evaluated Rybrevant as monotherapy as well as in combination with lazertinib. Rybrevant’s overall response rate (ORR) was 40% with 3.7% of patients having a complete response and 36% of patients achieving partial responses.1 Rybrevant launch and pricing are pending.

™ ● Camcevi (leuprolide mesylate): The FDA approved Foresee Pharmaceuticals’ Camcevi 42mg, a ready-to-use six-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer. The FDA approval was based on a single arm, Phase 3 study that demonstrated treatment with Camcevi injection every six months was effective, safe and well tolerated. The primary efficacy end point was the percentage of subjects with suppression of serum (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.2 Camcevi launch and pricing are pending.

™ ● Truseltiq (): The FDA has approved BridgeBioPharma’s Truseltiq under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic (CCA) harboring an FGFR2 fusion or rearrangement. Truseltiq is an orally administered, ATP-competitive, inhibitor of FGFR. CCA affects approximately 20,000 people in the United States and Europe each year and has a median five-year survival rate of 9%. The approval of Truseltiq was based on a Phase 2 clinical study where patients received 125 mg of Truseltiq once daily for 21 days of 28-day cycles. Of these patients, 99% had Stage IV CCA and all patients had received at least one prior line of systemic therapy. Truseltiq demonstrated an ORR of 23% and a median duration of response (DoR) of five months. Truseltiq has launched with a list price of $21,500 per month which is about 5% lower than Incyte’s Pemazyre, which has a similar indication.3

While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Specialty Pipeline Monthly Update: June 2021 Page 2

™ ● Lumakras (): Amgen’s Lumakras has received accelerated approval by the FDA for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. Approximately 13% of NSCLC patients have KRAS G12C mutations. Lumakras’ approval was based on the Phase 1/2 CODEBREAK 100, which demonstrated that previously treated patients with metastatic KRAS G12C-mutant NSCLC had a 36% ORR and an 81% of patients achieving disease control for more than three months.4 Lumakras has a median duration of response of 10 months. Lumakras has launched with a list price of about $17,900 per month or an average wholesale price (AWP) of $21,480 per 30-day supply (240-tab bottle). Amgen is currently assessing Lumakras in other solid tumors that have a similar KRAS mutation.5

® ● Ryplazim (plasminogen, human-tvmh): The FDA approved Liminal BioSciences’ Ryplazim for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia). Patients with congenital plasminogen deficiency experience an accumulation of fibrin growths or lesions on mucosal surfaces throughout the body. Many cases are first diagnosed in the pediatric population, and if left untreated, disease manifestations may be organ-compromising. Ryplazim’s BLA resubmission was based on a Phase 2/3, open-label study evaluating the safety and efficacy of Ryplazim in 15 patients, which demonstrated 100% of the patients enrolled met both primary efficacy endpoints of the clinical study.6 Primary endpoint was a surrogate target of increase in blood plasma concentration level of plasminogen. Additionally, all patients who had active visible lesions had complete healing of lesions, a 100% response rate, within one week. Ryplazim launch and price are pending.

® ● Aduhelm (aducanumab-avwa): The FDA granted accelerated approval to Biogen’s Aduhelm for the treatment of Alzheimer’s disease. The controversial approval was based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. In November 2020, The Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted no on several counts regarding the efficacy and evidence supporting the use of aducanumab in AD. Based on clinical trials, EMERGE and ENGAGE, eight experts voted no, aducanumab did not provide “strong evidence” in treating patients with Alzheimer’s, one expert voted yes, and two voted uncertain.7 In May 2021, the Institute for Clinical and Economic Review released a draft report estimating that the drug should cost between $2,560 to $8,290 per year, and noted that “the evidence is insufficient to conclude that the clinical benefits of aducanumab outweigh its harms or, indeed, that it reduces progression” of Alzheimer’s disease.8 The wholesale acquisition price (WAC) price of Aduhelm, which requires an infusion once every four weeks, is $4,312 per infusion, or an average of $56,000 annually based on a 74 kg person. Biogen plans to launch Aduhelm in the next few weeks.

® ● Epclusa pellets (sofosbuvir/velpatasvir): The FDA has approved an oral pellet formulation of Gilead Sciences’ hepatitis C drug Epclusa for use in young children who cannot swallow tablets as young as age three. Epclusa was originally approved by the FDA for adults in 2016 and then expanded their indication to include children six years of age and up. Epclusa pellets were approved based on one open-label Phase 2 trial that evaluated the efficacy and safety. Epclusa pellets demonstrated a sustained virologic response at a rate of 83% among all patients and 88% in patients with HCV genotype 1, 50% in patients with HCV genotype 2 and 100% in patients with HCV genotypes 3 and 4.9 The pellets are available in two dosages to accommodate children who weigh more or less than 17 kg. Each dose of the oral pellets comes in an individual packet that needs to be shaken, cut or torn open, and sprinkled onto food or directly into the mouths of people aged six years and older. Epclusa pellets launch and price are pending. Specialty Pipeline Monthly Update: June 2021 Page 3

® ● StrataGraft (bioengineered skin tissue): The FDA approved Mallinckrodt’s StrataGraft for the treatment of adult patients with thermal burns containing intact dermal elements (remaining deep skin layers) for which surgical intervention is clinically indicated, also referred to as deep, partial thickness burns. StrataGraft is produced from two kinds of human skin cells, keratinocytes and dermal fibroblasts, that are grown together to make a bi-layered construct. StrataGraft is for topical application, placed onto the burn by a health care provider. Over time, the patient’s skin cells should grow to replace the skin cells lost as a result of the burn. Treatment with StrataGraft can help avoid or decrease the amount of healthy skin that is needed for grafting. StrataGraft was approved based on the Phase 3 STRATA2016 that demonstrated 96% of the StrataGraft-treated burn sites across all participants did not require autografting.10 StrataGraft launch and price are pending.

NEW INDICATIONS

® ● Zeposia (): The FDA expanded the indication of Bristol-Myers Squibb’s Zeposia to include treatment of adults with moderately to severely active ulcerative colitis (UC).

® ● Ultomiris (-cwvz): The FDA expanded the indication of Alexion’s Ultomiris to include the treatment of pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).

® ● Ayvakit (): The FDA approved Blueprint Medicines Corp’s Ayvakit to include a new indication for treatment of adults with advanced systemic mastocytosis (SM).

MARCH NEWS

● “The FDA said that its Cardiovascular and Renal Drugs Advisory Committee of outside experts will convene on July 15 to review the safety and efficacy of FibroGen’s potential treatment for anemia in chronic kidney disease. The drug, known as roxadustat, has been hit with cardiovascular safety questions recently as the company had to double back and inform the FDA of some post-hoc changes. The announcement that an advisory committee would be necessary, which came in early March, also was a surprise. Wall Street biotech analysts and others like the Institute for Clinical and Economic Review (ICER) remain mixed on the drug overall. ICER said it determined that the evidence is insufficient to know whether roxadustat provides a net health benefit over an ESA, but at a placeholder price of $6,500 per year, roxadustat may be cost-saving in the dialysis independent population.”10

● “As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions. In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (three members of which have since resigned), and the wide label that the agency granted. In addition to requesting that Becerra seek the resignations or the removal of acting FDA commissioner Janet Woodcock, CDER Director Patrizia Cavazzoni, and Office of Neuroscience director Billy Dunn because of the approval, Public Citizen also wants Becerra to direct the next FDA commissioner to consider withdrawing the Aduhelm approval.”11 Specialty Pipeline Monthly Update: June 2021 Page 4

SPECIALTY NEW PRODUCT APPROVALS IN THE PAST TWELVE MONTHS ROUTE OF MONTH GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED bioengineered skin tissue StrataGraft™ Mallinckrodt Deep partial-thickness thermal Topical June 2021 burns sofosbuvir/velpatasvir Epclusa® pellets Gilead Hepatitis C Oral June 2021

aducanumab-avwa Aduhelm® Biogen Alzheimer’s disease IV June 2021

plasminogen (human-tvmh) Ryplazim® Prometic Life Plasminogen deficiency type 1 IV June 2021 Sciences Inc pegcetacoplan Empaveli® Apellis Paroxysmal nocturnal SC May 2021 hemoglobinuria Ponvory® Janssen Oral March 2021

fosdenopterin Nulibry® Origin Biosciences Molybdenum cofactor IV February 2021 (BridgeBio) deficiency (MoCD) Type A casimersen Amondys 45® Sarepta Duchenne muscular dystrophy IV February 2021 Therapeutics (DMD) Evkeeza™ Regeneron Homozygous familial IV February 2021 hypercholesterolemia (HoFH) voclosporin Lupkyis™ Aurinia nephritis Oral January 2021

ansuvimab-zykl Ebanga™ Ridgeback Treatment of Zaire ebolavirus IV December 2020 Biotherapeutics (Ebolavirus) infection berotralstat Orladeyo™ BioCryst Prevention of hereditary Oral December 2020 angioedema (HAE) attacks setmelanotide Imcivree™ Rhythm Certain types of genetic obesity SC November 2020 Pharmaceuticals lumasiran Oxlumo™ Alnylam Primary hyperoxaluria type 1 SC December 2020 (PH1) lonafarnib Zokinvy™ Eiger Progeria and progeroid Oral November 2020 BioPharmaceuticals laminopathies mannitol for inhalation Bronchitol™ Chiesi Group and Cystic fibrosis Inhaled November 2020 Pharmaxis remdesivir Veklury™ Gilead COVID-19 IV October 2020

atoltivimab, maftivimab and Inmazeb™ Regeneron Ebola IV October 2020 odesivimab-ebgn somapacitan-beco Sogroya™ Novo Nordisk Adult growth hormone SC August 2020 deficiency Kesimpta™ and Relapsing forms of multiple SC August 2020 sclerosis (RMS) cysteamine ophthalmic solution Cystadrops™ Recordati Rare Corneal cystine crystal deposits Eye drop August 2020 0.37% Disease -mwge Enspryng™ Roche Neuromyelitis optica spectrum SC August 2020 disorder (NMOSD) risdiplam Evrysdi™ Spinal muscular atrophy Oral August 2020

viltolarsen Viltepso™ Nippon Shinyaku Duchenne muscular dystrophy IV August 2020

triheptanoin Dojolvi™ Ultragenyx Long-chain fatty acid oxidation Oral July 2020 disorders calcium, magnesium, Xywav™ Jazz Excessive daytime sleepiness Oral July 2020 potassium, and sodium Pharmaceuticals oxybates Specialty Pipeline Monthly Update: June 2021 Page 5

NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION(S) DATE APPROVED ravulizumab-cwvz Ultomiris® Alexion Pediatric patients with paroxysmal nocturnal June 2021 hemoglobinuria (PNH) ozanimod Zeposia® Bristol-Myers Treatment of adults with moderatly to severely active May 2021 Squibb ulcerative colitis (UC) Xolair® Genentech New prefilled syringe for treatment of persistent April 2021 asthma and chronic idiopathic urticaria -rzaa Skyrizi® AbbVie New autoinjector and a prefilled syringe with needle April 2021 stock prevention for treatment of moderate-to- severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy treprostinil Tyvaso® United Pulmonary hypertension associated with interstitial March 2021 Therapeutics Corp lung disease to improve exercise ability Actemra® Genentech Slowing the rate of decline in pulmonary function March 2021 in adult patients with systemic sclerosis-associated interstitial lung disease Humira® AbbVie Moderately to severely active ulcerative colitis in February 2021 adults and pediatric patients five years of age and older Nplate® Amgen Increase survival in adults and in pediatric patients January 2021 (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome, or HSARS) carglumic acid Carbaglu® Recordati Rare Adjunctive therapy to standard of care for treatment January 2021 Diseases of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) ivacaftor Kalydeco® Vertex Expanded population cystic fibrosis patients with December 2020 Diagnostics additional rare CFTR mutations Kineret® Sobi Treatment of patients with Deficiency of IL-1 December 2020 Receptor Antagonist (DIRA) Ocrevus® Genentech Relapsing multiple sclerosis (RMS) and primary December 2020 progressive MS (PPMS) tezacaftor and ivacaftor Symdeko® Vertical Expanded population for the combination regimen December 2020 Pharmaceutical of the cystic fibrosis transmembrane conductance regulator (CFTR) corrector and the CFTR potentiator for treatment of cystic fibrosis patient Benlysta® GlaxoSmithKline December 2020

Arcalyst® Regeneron and Deficiency of the -1 receptor antagonist December 2020 Kiniksa (DIRA) pitolisant Wakix® Harmony Cataplexy in adults with narcolepsy October 2020 Biosciences ravulizumab-cwvz Ultomiris® Alexion Higher concentrations formula for paroxysmal October 2020 nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) C1 Esterase Inhibitor Haegarda® CSL Behring Routine prophylaxis of hereditary angioedema September 2020 Subcutaneous (Human) attacks in patients six years of age and older Simponi Aria® Johnson & Patients two years of age and older for the September 2020 Johnson (Janssen) treatment of active psoriatic arthritis (PsA) or active polyarticular juvenile idiopathic arthritis (pJIA) ivacaftor Kalydeco® Vertex Expanded population (ages four months to less than September 2020 six months old) for the combination regimen of the cystic fibrosis

continued Specialty Pipeline Monthly Update: June 2021 Page 6

NEW INDICATIONS FOR APPROVED SPECIALTY PRODUCTS (continued)

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION(S) DATE APPROVED Xeljanz® Pediatric patients two years and older with juvenile September 2020 idiopathic arthritis (pcJIA) Nucala® GlaxoSmithKline Pediatric patient 12 years and older with September 2020 hypereosinophilic syndrome (HES) dolutegravir and lamivudine Dovato® ViiV Healthcare Switch treatment for HIV-1 infection August 2020

cannabidiol Epidiolex® GW Seizures associated with tuberous sclerosis complex July 2020 Pharmaceuticals (TSC) in patients one year of age and older PLC

ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS ROUTE OF DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED sotorasib Lumakras® Amgen Certain forms of lung cancer Oral May 2021

infigratinib Truseltiq® QED Therapeutics Certain forms of Oral May 2021 (BridgeBio) cholangiocarcinoma leuprolide mesylate 50 mg Camcevi® 42mg Foresee Palliative treatment of advanced Injectable May 2021 depot Pharmaceuticals prostate cancer suspension amivantamab-vmjw Rybrevant™ Johnson & Certain forms of non-small cell IV May 2021 Johnson lung cancer -gxly Jemperli™ GlaxoSmithKline Endometrial cancer IV April 2021 (Tesaro) and AnaptysBio (lonca) Zynlonta™ ADC Therapeutics R/R diffuse large B-cell IV April 2021 (DLBCL) Fotivda™ Aveo Oncology Relapsed or refractory renal cell Oral March 2021 carcinoma (RCC) melphalan flufenamide Pepaxto™ Oncopeptides Certain forms of relapsed IV February 2021 refractory multiple myeloma (RRMM) Cosela™ G1 Therapeutics Myelopresservation IV February 2021

umbralisib Ukoniq™ TG Therapeutics Marginal zone lymphoma (MZL) Oral February 2021

Tepmetko® EMD Serono Certain forms of metastatic non- Oral February 2021 small cell lung cancer (NSCLC) relugolix Orgovyx™ Myovant Prostate cancer Oral December 2020

-cmkb Margenza™ MacroGenics Breast cancer IV December 2020

-gqgk Danyelza™ Y-mAbs Relapsed or refractory high-risk IV November 2020 Gavreto™ Blueprint RET fusion-positive non-small Oral September 2020 cell lung cancer (NSCLC) azacitidine Onureg™ Bristol-Myers Acute myeloid (AML) Oral September 2020 Squibb cedazuridine and decitabine, Inqovi™ Astex Myelodysplastic syndrome Oral August 2020 C-DEC Pharmaceuticals (MDS) (Otsuka) -cxix Monjuvi™ MorphoSys AG Relapsed/refractory diffuse large IV August 2020 B cell lymphoma

continued Specialty Pipeline Monthly Update: June 2021 Page 7

ONCOLOGY PRODUCT APPROVALS IN THE PAST TWELVE MONTHS (continued) ROUTE OF DATE GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED -blmf Blenrep™ GlaxoSmithKline Multiple myeloma IV August 2020

lurbinectedin Zepzelca™ PharmaMar Small cell lung cancer (SCLC) IV August 2020 and Jazz Pharmaceuticals decitabine and cedazuridine Inqovi™ Astex Myelodysplastic syndromes Oral July 2020 Pharmaceuticals (MDS) and chronic myelomonocytic leukemia (CMML)

NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION DATE APPROVED avapritinib Ayvakit® Blueprint Adults with advanced systemic mastocytosis (SM) June 2021 Medicines Corp Keytruda® Merck Certain combination for first-line treatment of May 2021 patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma Opdivo® Bristol-Myers Adjuvant treatment of patients with resected May 2021 Squibb esophageal or gastroesophageal junction (GEJ) cancer after neoadjuvant chemoradiation therapy (CRT) nivolumab Opdivo® Bristol-Myers Certain forms of advanced or metastatic gastric May 2021 Squibb cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC) Lorbrena® Pfizer Treatment of previously untreated advanced ALK- April 2021 positive non-small cell lung cancer (NSCLC) -hziy Trodelvy® Gilead Sciences Triple-negative breast cancer that has spread to April 2021 other parts of the body nivolumab Opdivo® Bristol-Myers Initial treatment of patients with advanced or April 2021 Squibb metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma pembrolizumab Keytruda® Merck Certain forms of locally advanced unresectable March 2021 or metastatic carcinoma of the esophagus and gastroesophageal junction (GEJ) axicabtagene ciloleucel Yescarta® Kite Pharm Relapsed or refractory and March 2021 marginal zone lymphoma after two or more prior lines of systemic therapy cytarabine and daunorubicin Vyxeos® Jazz Certain forms of acute myeloid leukemia (t-AML) or March 2021 Pharmaceuticals AML with myelodysplasia-related changes (AML- MRC) sacituzumab govitecan-hziy Trodelvy® Gilead Sciences Adult patients with locally advanced or metastatic March 2021 urothelial cancer (UC) -irfc Sarclisa® Sanofi PS Multiple myeloma who have received at least one March 2021 prior therapy -rwlc Libtayo® Regeneron Monotherapy for treatment of first line locally February 2021 advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression cemiplimab-rwlc Libtayo® Regeneron Treatment of locally advanced or metastatic basal February 2021 cell carcinoma (BCC)

continued Specialty Pipeline Monthly Update: June 2021 Page 8

NEW INDICATIONS FOR APPROVED ONCOLOGY DRUGS (continued)

GENERIC NAME BRAND NAME MANUFACTURER NEW INDICATION DATE APPROVED pralsetinib Gavreto® Blueprint Treatment of patients with advanced or metastatic February 2021 medicines RET mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid . darolutamide Nubeqa® Bayer Non-metastatic castration-dependent prostate January 2021 Pharmaceutical cancer and Darzalex Faspro® Janssen Biotech Light chain (AL) amyloidosis January 2021 hyaluronidase-fihj and Genmab fam- deruxtecan- Enhertu® Daiichi Patients with HER2-positive metastatic gastric or January 2021 nxki Pharmaceutical gastroesophageal junction (GEJ) adenocarcinoma Cabometyx® Exelixis In combination with the immuno-oncologic January 2021 nivolumab (Bristol-Myers Squibb's Opdivo) for first-line treatment of advanced renal cell carcinoma (RCC) nivolumab Opdivo® Bristol-Myers In combination with cabozantinib (Exelixis' January 2021 Squibb Cabometyx) for first-line treatment of advanced renal cell carcinoma (RCC) Xalkori® Pfizer Pediatric patients with certain forms of relapsed or January 2021 refractory systemic anaplastic large cell lymphoma selinexor Xpovio® Karyopharm Treatment of patients with multiple myeloma after at December 2020 least one prior line of therapy Tagrisso® AstraZeneca Adjuvant treatment of patients with early-stage December 2020 (IB, II and IIIA) epidermal - mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent Iclusig® Takeda Chronic-phase (CP) chronic myeloid leukemia (CML) December 2020 Pharmaceuticals with resistance Imfinzi® AstraZeneca New four-week, fixed-dose regimen for the PD- November 2020 L1 inhibitor immuno-oncologic, consistent with approved dosing in extensive-stage small cell lung cancer (ES-SCLC), for Imfinzi's approved indications in urothelial cancer and non-small cell lung cancer (NSCLC) pembrolizumab Keytruda® Merck In combination with chemotherapy for treatment November 2020 of patients with locally recurrent unresectable or metastatic triple negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) pembrolizumab Keytruda® Merck Monotherapy for treatment of adults with relapsed October 2020 or refractory classical Hodgkin lymphoma (cHL) nivolumab and Opdivo® and Bristol-Myers First line treatment for malignant pleural October 2020 Yervoy® Squibb mesothelioma daratumumab Darzalex® Johnson & New combination for treatment of relapsed or August 2020 Johnson (Janssen) refractory multiple myeloma carfilzomib Kyprolis® Amgen New combination for treatment of relapsed or August 2020 refractory multiple myeloma Tecentriq® Genentech New combination for treatment of patients with July 2020 (Roche) unresectable or metastatic BRAF V600 mutation- positive Tremfya® Johnson & Adults with active psoriatic arthritis (PsA) July 2020 Johnson Specialty Pipeline Monthly Update: June 2021 Page 9

BIOSIMILAR PRODUCT APPROVALS IN THE PAST TWELVE MONTHS REFERENCE ROUTE OF MONTH GENERIC NAME BRAND NAME PRODUCT MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED -arrx Riabni™ Rituxan® Amgen Oncology IV December 2020

adalimumab-fkjp Hulio™ Humira® Mylan Autoimmune SC July 2020

SPECIALTY PIPELINE ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE* eflapegrastim Rolontis™ Spectrum Chemotherapy-induced SC Delayed- 2021 Pharmaceuticals and Hanmi Pharmaceutical CPP-1X/sul (eflornithine N/A Cancer Prevention Familial adenomatous polyposis Oral Delayed- 2021 and sulindac) Pharmaceuticals (FAP) N/A Pfizer And Lilly Osteoarthritis SC 2Q2021

NexoBrid N/A MediWound Burn tissue Gel June 2021

Leukotac® Farmaceutici Spa Steroid-refractory acute graft- IV 1H2021 versus-host disease roxadustat N/A FibroGen Inc. and Anemia of chronic kidney disease Oral 3Q2021 AstraZeneca PLC (CKD) N/A Pfizer And Lilly Atopic dermatitis Oral July 2021

Tzield® Provention Bio Diabetes IV July 2021

retifanlimab N/A Incyte Corporation Certain forms of squamous cell IV July 2021 carcinoma avacopan N/A Chemocentryx ANCA-associated vasculitis Oral July 2021

odevixibat Bylvay® Albireo Progressive familial intrahepatic Oral July 2021 cholestasis donislecel purified Lantidra® CellTrans Brittle type 1 diabetes IV July 2021 allogeneic deceased donor pancreas derived islets of Langerhans N/A UCB Psoriasis SC August 2021

N/A TG Therapeutics Certain forms of chronic IV August 2021 lymphocytic leukemia (CLL) belumosudil N/A Kadmon Chronic graft-versus-host disease Oral August 2021 (cGVHD) selexipag Uptravi® Johnson & Johnson Pulmonary arterial hypertension IV August 2021

-fnia Saphnelo® AstraZeneca Systemic lupus erythematosus IV August 2021 (SLE) vosoritide N/A BioMarin Achondroplasia SC August 2021

Vicinium® Sensen Certain forms of bladder cancer Intravesical August 2021

avalglucosidase alfa N/A Sanofi-Aventis Pompe disease IV August 2021

SH-111 N/A Shorla Pharma Pediatric patients with T-cell IV August 2021 leukemia

continued Specialty Pipeline Monthly Update: June 2021 Page 10

SPECIALTY PIPELINE (continued) ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE* belzutifan N/A Merck Von Hippel-Lindau (VHL) disease Oral September 2021

maralixibat N/A Mirum Alagille syndrome (ALGS) Oral September 2021 Pharmaceuticals N/A Incyte Corporation Atopic dermatitis Topical September 2021

lonapegsomatropin N/A Acendis Growth hormone deficiency (GHD) SC September 2021 (TransCon hGH) mobocertinib (TAK-788) N/A Takeda Metastatic non-small cell lung Oral October 2021 Pharmaceuticals cancer (mNSCLC) tisotumab vedotin N/A Seagen Certain forms of cervical cancer IV October 2021

somatrogon N/A Pfizer Growth hormone deficiency Pen injector October 2021

FT218 (sodium oxybate, N/A Avadel Narcolepsy Oral October 2021 controlled release) Pharmaceuticals bimekizumab N/A UCB Pharma Psoriasis SC October 2021

narsoplimab N/A Omeros Hematopoietic stem cell IV or SC October 2021 transplant-associated thrombotic microangiopathy ropeginterferon alfa-2b N/A PharmaEssentia Polycythemia vera (PV) SC November 2021

plinabulin N/A BeyondSpring Neutropenia IV November 2021

palovarotene N/A Ipsen (Clementia) Fibrodysplasia ossificans Oral November 2021 progressiva (FOP) N/A CTI BioPharma Myelofibrosis patients with severe Oral November 2021 thrombocytopenia oleogel-S10 Filsuvez® Amryt Pharma Dystrophic epidermolysis bullosa Topical November 2021

efgartigimod N/A Argenx Generalized myasthenia gravis IV December 2021

levoketoconazole Recorlev® Strongbridge Cushing’s syndrome Oral January 2022 Biopharma mavacamten N/A Bristol-Myers Squibb Symptomatic obstructive Oral January 2022 hypertrophic cardiomyopathy (oHCM) bardoxolone N/A Reata Autosomal dominant polycystic Oral February 2022 Pharmaceuticals kidney disease GC5107 (immune globulin N/A GC Pharma Primary humoral immunodeficiency IV February 2022 intra-venous [human], 10% liquid) sintilimab N/A Innovent Biologics Nonsquamous non-small cell lung IV March 2022 and Lilly cancer (NSCLC) vadadustat N/A Akebia Therapeutics Anemia due to chronic kidney Oral March 2022 disease (CKD) * Anticipated approval dates are predictions made by Prime Therapeutics based on industry information. Specialty Pipeline Monthly Update: June 2021 Page 11

BIOSIMILAR PIPELINE ANTICIPATED ROUTE OF APPROVAL GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION DATE*

Oncology MYL-1402O N/A (Avastin® biosimilar) Mylan NV and Oncology IV 2021 Biocon Ltd. SB8 N/A (Avastin® biosimilar) Samsung Bioepis Oncology IV 2021 and Merck FKB238 N/A (Avastin® biosimilar) Centus Oncology IV 2021 Biotherapeutics BAT-1706 N/A (Avastin® biosimilar) Bio-thera solutions Oncology IV November 2021

Blood modifiers MSB11455 Stimufend® (Neulasta® Fresenius Kabi Neutropenia IV or SC 2021 biosimilar) TPI-120 N/A (Neulasta® biosimilar) Amneal and Kashiv Neutropenia IV or SC 2022 (Adello) lupifil-p N/A (Neulasta® biosimilar) Lupin Neutropenia SC April 2022

kashiv N/A (Neupogen® Adello Biologics Neutropenia IV 2021 biosimilar) TX-01 N/A (Neupogen® Tanvex BioPharma Neutropenia SC 2021 biosimilar)

Ophthalmology SB11 N/A (Lucentis® biosimilar) Samsung Bioepis Age-related macular Injection into the September 2021 degeneration eye FYB201 N/A (Lucentis® biosimilar) Coheres Age-elated macular Injection into the 2022 biosciences/bioeq degeneration eye

Autoimmune AVT02 N/A (Humira® biosimilar) Alvotech Autoimmune SC September 2021

CHS-1420 N/A (Humira® biosimilar) Coherus Autoimmune SC December 2021

FDA APPROVED GENE/CELL THERAPY NEW PRODUCT APPROVALS ROUTE OF MONTH GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVED idecabtagene Abecma™ Bristol-Myers Multiple myeloma CAR-T March 2021 vicleucel (bb2121, Squibb and ide-cel) bluebird bio lisocabtagene Breyanzi™ Bristol-Myers R/R large B cell lymphoma IV February 2021 maraleucel Squibb (liso‑cel) brexucabtagene Tecartus™ Kite Mantle cell lymphoma CAR T-cell therapy July 2020 autoleucel onasemnogene Zolgensma™ AveXis Spinal Muscular Atrophy IV May 2019 abeparvovec-xioi voretigene Luxturna® Spark Therapeutics Biallelic RPE65 mutation- Subretinal injection December 2017 neparvovec-rzyl associated retinal dystrophy axicabtagene Yescarta® Kite Large B-cell lymphoma IV October 2017 ciloleucel tisagenlecleucel Kymriah® Novartis Acute lymphoblastic leukemia IV August 2017 Specialty Pipeline Monthly Update: June 2021 Page 12

GENE/CELL THERAPY 2021 PIPELINE ROUTE OF ANTICIPATED GENERIC NAME BRAND NAME MANUFACTURER INDICATION(S) ADMINISTRATION APPROVAL DATE ciltacabtagene N/A Johnson & Johnson Relapsed and refractory CAR-T November 2021 autoleucel (Janssen) multiple myeloma (cilta‑cel) RVT-802 N/A Enzyvant Pediatric congenital athymia IV 2021

loncastuximab N/A ADC Therapeutics Relapsed or refractory diffuse IV 2021 tesirine (Lonca) large B-cell lymphoma (DLBCL)

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