Biosimilar Medications

POLICY NUMBER

L.5.01.593

Abrilada (adalimumab-afzb)                 Ogivri (trastuzumab-dkst)

Alymsys (bevacizumab-maly)               Ontruzant (trastuzumab-dttb)

Amjevita (adalimumab-atto)                 Otulfi (ustekinumab-aauz)

Avastin (bevacizumab)                         Pyzchiva (ustekinumab-ttwe)

Avsola (infliximab-axxq)                       Releuko (filgrastim-ayow)

Byooviz (ranibizumab-nuna)                 Remicade (infliximab)

Cimerli (ranibizumab-eqrn)                   Renflexis (infliximab-abda)

Cyltezo (adalimumab-adbm)                 Riabni (rituximab-arrx)

Fulphila (pegfilgrastim-jmdb)                Rituxan (rituximab)

Fylnetra (pegfilgrastim-pbbk)                Ruxience (rituximab-pvvr)

Hadlima (adalimumab-bwwd)                Selarsdi (ustekinumab-aekn)

Herceptin (trastuzumab)                       Simlandi (adalimumab-ryvk)

Hercessi (trastuzumab-strf)                   Stelara (ustekinumab)

Herzuma (trastuzumab-pkrb)                 Stimufend (pegfilgrastim-fpgk)

Hulio (adalimumab-fkjp)                        Steqeyma (ustekinumab-stba)

Humira (adalimumab)                           Trazimera (trastuzumab-qyyp)

Hyrimoz (adalimumab-adaz)                  Truxima (rituximab-abbs)

Idacio (adalimumab-aacf)                      Tofidence (tocilizumab-bavi)

Imuldosa (ustekinumab-srlf)                  Tyenne (tocilizumab-aazg)

Inflectra (infliximab-dyyb)                      Udenyca (pegfilgrastim-cbqv)

Infliximab                                             Udenyca Onbody (pegfilgrastim-cbqv)

Kanjinti (trastuzumab-anns)                   Vegzelma (bevacizumab-adcd)

Lucentis (ranibizumab)                          Wezlana (ustekinumab-auub)

Mvasi (bevacizumab-awwb)                    Yesintek (ustekinumab-kfce)

Neulasta (pegfilgrastim)                         Yuflyma (adalimumab-aaty)

Neulasta Onpro (pegfilgrastim)               Yusimry (adalimumab-aqvh)

Neupogen (filgrastim)                            Zarxio (filgrastim-sndz)

Nivestym (filgrastim-aafi)                       Ziextenzo (pegfilgrastim-bmez)

Nypozi (filgrastim-txid)                          Zirabev (bevacizumab-bvzr)

Nyvepria (pegfilgrastim-apgf)

 Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Biological Products

Biological products are regulated by the Food and Drug Administration (FDA) and are used to diagnose, prevent, treat and cure diseases and medical conditions. Biological products are a diverse category of products and are generally large, complex molecules. These products may be produced through biotechnology in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs.

The nature of biological products, including the inherent variations that can result from the manufacturing process, can present challenges in characterizing and manufacturing these products that often do not exist in the development of small molecule drugs. Slight differences between manufactured lots of the same biological product (i.e., acceptable within-product variations) are normal and expected within the manufacturing process. As part of its review, FDA assesses the manufacturing process and the manufacturer’s strategy to control within-product variations. These control strategies are put in place to help ensure that manufacturers produce biological products with consistent clinical performance.

A biosimilar is a type of biologic that is highly similar to an already approved biologic medicine. To be called a biosimilar drug, a biological drug must be shown to be as safe as, work as well as, and work in the same way as its reference drug.

Reference Products

A reference product is the single biological product, already approved by FDA, against which a proposed biosimilar product is compared. A reference product is approved based on a full complement of safety and effectiveness data. A proposed biosimilar product is compared to and evaluated against a reference product to ensure that the product is highly similar and has no clinically meaningful differences.

Biosimilar Products

Biosimilar products are versions of reference products and may offer more affordable treatment options to patients. Biosimilar products are approved through different abbreviated pathways that avoid duplicating costly clinical trials. Biosimilar products are not generics, and there are important differences between biosimilar and generic drugs. Generic drugs contain the same active ingredient of the brand name drug. Biosimilar manufacturers must demonstrate that the biosimilar is highly similar to the reference product, except for minor differences in clinically inactive components. Biosimilar manufacturers must also demonstrate that there are no clinically meaningful differences between the biosimilar and the reference product in terms of potency, safety and effectiveness. FDA requires biosimilar products to meet the Agency’s rigorous approval standards. Patients and health care professionals are able to rely upon the safety and effectiveness of the biosimilar product, just as they would the reference product.

The covered and non-covered/non-formulary biologic agents/biosimilar products addressed in this policy are as follows:

^{*Medications listed above include both branded and unbranded versions of the product unless otherwise specified.1}Avastin may be preferred product for ocular disease indications only as outlined in the  Intravitreal Angiogenesis Inhibitors medical policy.

  Related policies -

• Rituximab Non-Oncology

• Intravitreal Angiogenesis Inhibitors

• Anti-Rheumatic Biologicals

• Chronic Plaque Psoriasis

• Crohn's Disease and Ulcerative Colitis

• Hidradenitis Suppurativa (HS)

• Uveitis

• Interstitial Lung Disease

• Giant Cell Arteritis

• Treatment of Coronavirus Disease 2019 (COVID-19)

POLICY

This policy statement applies to clinical review performed for pre-service (Prior Approval, Care Coordination, etc.) and/or post-service claims.

The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.

• Hadlima and Simlandi are the covered adalimumab products.

• Mvasi and Zirabev are the covered bevacizumab products.

• Nivestym and Zarxio are the covered filgrastim products.

• Inflectra,infliximab, and Remicade are the covered infliximab products.

• Neulasta, Neulasta Onpro,Udenyca, and Udenyca Onbody are the covered pegfilgrastim products.

• Byooviz and Lucentis are the covered ranibizumab products.

• Ruxience and Truxima are the covered rituximab products.

• Tyenne is the covered tocilizumab product.

• Kanjinti and Trazimera are the covered trastuzumab products.

• Selarsdi, Steqeyma, and Yesintek are the covered ustekinumab products. 

Services related to delivery and/or administration of a not covered/non-formulary medication will be considered not medically necessary.

POLICY EXCEPTIONS

Federal Employee Program (FEP): Refer to the FEP Medical Policy Manual .

State Health Plan (State and School Employees) Participants

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

1. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

2. appropriate with regard to standards of good medical practice; and

3. not solely for the convenience of the Member, his or her Provider; and

4. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

02/28/2023: New policy added. Effective 04/01/2023.

03/23/2023: Policy updated to add Releuko (filgrastim-ayow) and Stimufend (pegfilgrastim-fpgk) to the list of medications. Policy description updated to add Stimufend as a non-preferred product for pegfilgrastim. Policy statements unchanged. Code Reference section updated to remove HCPCS code J3590 and add Q5127, Q5129, and Q5130 to the Not Medically Necessary Codes table. Policy effective 04/01/2023.

03/31/2023: Revised the code description for HCPCS codes Q5108, Q5111, Q5120, and Q5122. Policy effective 04/01/2023.

07/01/2023: Policy description updated regarding preferred and non-preferred products. Added related policies to the policy description. Policy section updated to add the preferred products for adalimumab, infliximab, and pegfilgrastim. Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants. Code Reference section updated to add HCPCS codes J1745, Q5111, and Q5121 to the Medically Necessary Codes table and HCPCS codes Q5103, Q5104, Q5109, and Q5120 to the Not Medically Necessary Codes table.

09/18/2023: Code Reference section updated to add new HCPCS code Q5131.

10/01/2023: Policy updated to include Byooviz (ranibizumab-nuna), Cimerli (ranibizumab-eqrn), and Lucentis (ranibizumab) to the list of medications. Policy updated to add the preferred products for ranibizumab. Code Reference section updated to add HCPCS codes J2778 and Q5124 to the Medically Necessary Codes table. Added HCPCS code Q5128 to the Not Medically Necessary Codes table.

03/08/2024: Policy description updated to move Amjevita from Preferred to Non-Preferred for adalimumab. Policy statement updated to remove Amjevita as a preferred adalimumab product.

05/13/2024: Policy updated to add Simlandi as a preferred product for adalimumab.

05/31/2024: Policy updated to state that Hadlima or Simlandi are the adalimumab formulary options for new starts effective 07/01/2024.

11/01/2024: Effective 01/01/2025 - Policy description updated to change "Preferred Product(s)" to "Covered Products" and "Non-Preferred Product(s)" to "Not Covered/Non-Formulary Products." Humira and Avsola moved from Covered to Not Covered/Non-Formulary. Inflectra moved from Not Covered to Covered. Added indication for tocilizumab which includes Tyenne as Covered and Actemra and Tofidence as Not Covered/Non-Formulary. Updated related policies. Revised policy statement to state that the use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Removed language regarding "Generic First" and the use of a non-preferred biologic agent/biosimilar from policy. Removed Humira as a covered adalimumab product. Removed Avsola as a covered infliximab product and added Inflectra. Added Tyenne as the covered tocilizumab product. Revised policy statement to state that services related to delivery and/or administration of a not covered/non-formulary medication will be considered not medically necessary. Sources updated. Code Reference section updated to add HCPCS codes Q5103 and Q5135 to the Medically Necessary Codes table. Added HCPCS codes J3262, Q5111, Q5121, and Q5133 to the Not Covered/Non-Formulary Codes table. Removed Ixifi (infliximab-qbtx) from the policy as it is no longer on the market. Policy update effective 01/01/2025.

01/01/2025: Policy updated to add Nypozi (filgrastim-txid). Code Reference section updated to add new HCPCS codes C9173, J0139, Q5140, Q5141, Q5142, Q5143, and Q5145.

03/21/2025: Policy description table of products updated to move Truxima from "Not Covered/Non-Formulary" to "Covered" for rituximab. Policy statement revised to state that Ruxience and Truxima are the covered rituximab products. Code Reference section updated to move HCPCS code Q5115 from the Not Covered/Non-Formulary Codes table to the Medically Necessary Codes table.

04/01/2025: Code Reference section updated to add new HCPCS code Q5148, effective 04/01/2025.

06/13/2025: Policy description updated to add Nypozi to the list of "Not Covered/Non-Formulary Products" for filgrastim. Added note that the medications listed in the table include both branded and unbranded versions of the product unless otherwise specified. Sources updated.

07/01/2025: Policy updated to add Otulfi (ustekinumab-aauz), Pyzchiva (ustekinumab-ttwe), Selarsdi (ustekinumab-aekn), Stelara (ustekinumab), Steqeyma (ustekinumab-stba), Wezlana (ustekinumab-auub), and Yesintek (ustekinumab-kfce). Table in policy description updated to list Selarsdi, Stelara, Steqeyma, and Yesintek as covered products for ustekinumab. Added Otulfi, Pyzchiva, and Wezlana as not covered/non-formulary products for ustekinumab. Added note in policy description and Policy section stating that Stelara will no longer be covered effective 8/1/25. Policy section updated to state that Selarsdi, Stelara, Steqeyma, and Yesintek are the covered ustekinumab products. Code Reference section updated to add HCPCS codes J3357, J3358, Q5099, Q5100, and Q9998 to the Medically Necessary Codes table. Added HCPCS Codes Q5137, Q5138, Q9996, Q9997, and Q9999 to the Not Covered/Non-Formulary Codes table.

07/18/2025: Code Reference section updated to make note of deleted HCPCS code C9173.

08/01/2025: Policy description updated to remove Stelara from the list of covered products for ustekinumab. Added Hercessi to the list of Not Covered/Non-Formulary Products for trastuzumab. Added Imuldosa and Stelara to the list of Not Covered/Non-Formulary Products for ustekinumab. Policy statement updated to remove Stelara from the list of covered ustekinumab products. Sources updated. Code Reference section updated to add HCPCS codes J3357, J3358, Q5098, and Q5146 to the Not-Covered/Non-Formulary Codes table.

12/02/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Sources updated.

SOURCE(S)

U.S. Food and Drug Administration: https://www.fda.gov/drugs/therapeutic-biologics-applications-bla/biosimilars. Accessed 11/04/2025.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Covered/Non-Formulary Codes

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