Biosimilar/ja: Difference between revisions

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欧州連合（EU）で承認されたバイオシミラー医薬品は、参照薬または同等のバイオシミラー医薬品と互換性がある。

~~<div lang="en" dir="ltr" class="mw-content-ltr">~~

{| class="wikitable"

|+~~European Union approved biosimilars~~

|+欧州連合が承認したバイオシミラー

|-

! ~~Active substance~~ !! ~~Reference product~~ !! ~~Biosimilar medicines~~

! 活性物質 !! 参照商品 !! バイオシミラー医薬品

|-

| [[Adalimumab]] || Humira || Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma

| [[Adalimumab/ja]] || Humira || Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma

|-

| [[Bevacizumab]] || Avastin || Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev

| [[Bevacizumab/ja]] || Avastin || Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev

|-

| [[Enoxaparin sodium]] || Clexane|| Inhixa, Thorinane

| [[Enoxaparin sodium/ja]] || Clexane|| Inhixa, Thorinane

|-

| [[Epoetin alfa]] || Eprex/Erypo || Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo

| [[Epoetin alfa/ja]] || Eprex/Erypo || Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo

|-

| [[Etanercept]] || Enbrel || Benepali, Erelzi, Lifmior, Nepexto

| [[Etanercept/ja]] || Enbrel || Benepali, Erelzi, Lifmior, Nepexto

|-

| [[Filgrastim]] || Neupogen || Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio

| [[Filgrastim/ja]] || Neupogen || Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio

|-

| [[Follitropin alfa]] || Gonal-F || Bemfola, Ovaleap

| [[Follitropin alfa/ja]] || Gonal-F || Bemfola, Ovaleap

|-

| [[Infliximab]] || Remicade || Flixabi, Inflectra, Remsima, Zessly

| [[Infliximab/ja]] || Remicade || Flixabi, Inflectra, Remsima, Zessly

|-

| [[Insulin aspart]] || NovoRapid || Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg

| [[Insulin aspart/ja]] || NovoRapid || Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg

|-

| [[Insulin glargine]] || Lantus || Abasaglar, Semglee

| [[Insulin glargine/ja]] || Lantus || Abasaglar, Semglee

|-

| [[Insulin lispro]] || Humalog || Insulin lispro Sanofi

| [[Insulin lispro/ja]] || Humalog || Insulin lispro Sanofi

|-

| [[Pegfilgrastim]] || Neulasta || Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo

| [[Pegfilgrastim/ja]] || Neulasta || Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo

|-

| [[Ranibizumab]] || Lucentis || Byooviz, Ranivisio, Ximluci

| [[Ranibizumab/ja]] || Lucentis || Byooviz, Ranivisio, Ximluci

|-

| [[Rituximab]] || MabThera || Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima

| [[Rituximab/ja]] || MabThera || Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima

|-

| [[Somatropin]] || Genotropin || Omnitrope

| [[Somatropin/ja]] || Genotropin || Omnitrope

|-

| [[Teriparatide]] || Forsteo || Movymia, Terrosa

| [[Teriparatide/ja]] || Forsteo || Movymia, Terrosa

|-

| [[Tocilizumab]] || RoActemra || Tyenne

| [[Tocilizumab/ja]] || RoActemra || Tyenne

|-

| [[Trastuzumab]] || Herceptin || Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac

| [[Trastuzumab/ja]] || Herceptin || Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac

|}

~~</div>~~

~~<div lang~~=~~"en" dir~~=~~"ltr" class~~=~~"mw-content-ltr">~~

== アメリカ ==

== United States ==

~~</div>~~

~~<div lang="en" dir="ltr" class="mw-content-ltr">~~

===BPCI法===

===~~BPCI Act~~===

[[:en:Biologics Price Competition and Innovation Act of 2009|2009年生物製剤価格競争・革新法]]（Biologics Price Competition and Innovation Act of 2009: BPCI Act）は、2007年6月26日に[[:en:Ted Kennedy|エドワード・ケネディ]]上院議員（民主党）によって提唱・提出された。2010年3月23日にバラク・オバマ大統領によって署名された[[:en:Patient Protection and Affordable Care Act|患者保護と医療費負担適正化法]]（PPAC法）の下で正式に成立した。BPCI法は、公衆衛生法（PHS法）を改正し、[[Food and Drug Administration/ja|食品医薬品局]]（FDA）が承認した生物学的製剤と高度に類似（バイオシミラー）していることが実証された生物学的製剤について、短縮された承認経路を設けるものである。BPCI法は、1984年に連邦食品医薬品化粧品法（Federal Food, Drug, and Cosmetic Act：FFD&C法）を通じて生物学的製剤の承認を定めた薬物価格競争及び特許期間回復法（Drug Price Competition and Patent Term Restoration Act of 1984：ハッチ・ワックスマン法）と概念的に類似している。BPCI法は、薬物について既に知られていることを適切に利用することで、時間と資源を節約し、不必要な人体・動物実験の重複を避けるというFDAの長年の方針と一致している。FDAは、バイオシミラーまたはバイオ後続品開発に関連する合計4つのガイドライン草案を発表した。最初の3つのガイダンス文書が発表されると、FDAは2012年5月11日に公聴会を開催した。

~~The~~ [[Biologics Price Competition and Innovation Act of 2009|~~Biologics~~ Price Competition and Innovation Act]] of 2009 (BPCI ~~Act) was originally sponsored and introduced on June 26, 2007, by Senator~~ [[Ted Kennedy|~~Edward Kennedy~~]] ~~(D-MA). It was formally passed under the~~ [[Patient Protection and Affordable Care Act]] (PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a [[Food and Drug Administration]] ~~(FDA) approved biological product. The BPCI Act is similar~~, ~~conceptually~~, ~~to the Drug~~ Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012.

~~</div>~~

~~<div lang="en" dir="ltr" class="mw-content-ltr">~~

2018年、FDAはBPCIによる規制を実施するための「バイオシミラー行動計画」を発表し、[[evergreening/ja|エバーグリーニング]]のためのリスク評価・軽減戦略（REMS）制度の乱用の制限や、インスリンとヒト成長ホルモンを薬物ではなく生物製剤としての規制に移行させることなどが盛り込まれた。

~~In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for~~ [[evergreening]] ~~and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.~~

~~</div>~~

===アメリカで承認されたバイオシミラー===

@@ Line 71: / Line 71: @@
 欧州連合（EU）で承認されたバイオシミラー医薬品は、参照薬または同等のバイオシミラー医薬品と互換性がある。
-<div lang="en" dir="ltr" class="mw-content-ltr">
 {| class="wikitable"
-|+European Union approved biosimilars
+|+欧州連合が承認したバイオシミラー
 |-
-! Active substance !! Reference product !! Biosimilar medicines
+! 活性物質 !! 参照商品 !! バイオシミラー医薬品
 |-
-| [[Adalimumab]]  || Humira || Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma
+| [[Adalimumab/ja]]  || Humira || Amgevita, Amsparity, Cyltezo, Halimatoz, Hefiya, Hukyndra, Hulio, Hyrimoz, Idacio, Imraldi, Kromeya, Libmyris, Solymbic, Trudexa, Yuflyma
 |-
-| [[Bevacizumab]] || Avastin || Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev
+| [[Bevacizumab/ja]] || Avastin || Abevmy, Alymsys, Aybintio, Equidacent, Mvasi, Onbevzi, Oyavas, Vegzelma, Zirabev
 |-
-| [[Enoxaparin sodium]]  || Clexane|| Inhixa, Thorinane
+| [[Enoxaparin sodium/ja]]  || Clexane|| Inhixa, Thorinane
 |-
-| [[Epoetin alfa]] || Eprex/Erypo || Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo
+| [[Epoetin alfa/ja]] || Eprex/Erypo || Abseamed, Binocrit, Epoetin Alfa Hexal, Retacrit, Silapo
 |-
-| [[Etanercept]]  || Enbrel || Benepali, Erelzi, Lifmior, Nepexto
+| [[Etanercept/ja]]  || Enbrel || Benepali, Erelzi, Lifmior, Nepexto
 |-
-| [[Filgrastim]]  || Neupogen || Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio
+| [[Filgrastim/ja]]  || Neupogen || Accofil, Biograstim, Filgrastim Hexal, Filgrastim ratiopharm, Grastofil, Nivestim, Ratiograstim, Tevagrastim, Zarzio
 |-
-| [[Follitropin alfa]] || Gonal-F || Bemfola, Ovaleap
+| [[Follitropin alfa/ja]] || Gonal-F || Bemfola, Ovaleap
 |-
-| [[Infliximab]]  || Remicade || Flixabi, Inflectra, Remsima, Zessly
+| [[Infliximab/ja]]  || Remicade || Flixabi, Inflectra, Remsima, Zessly
 |-
-| [[Insulin aspart]]  || NovoRapid || Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg
+| [[Insulin aspart/ja]]  || NovoRapid || Fiasp, Insulin aspart Sanofi, Kirsty, NovoMix, Ryzodeg
 |-
-| [[Insulin glargine]]  || Lantus || Abasaglar, Semglee
+| [[Insulin glargine/ja]]  || Lantus || Abasaglar, Semglee
 |-
-| [[Insulin lispro]]  || Humalog || Insulin lispro Sanofi
+| [[Insulin lispro/ja]]  || Humalog || Insulin lispro Sanofi
 |-
-| [[Pegfilgrastim]] || Neulasta || Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo
+| [[Pegfilgrastim/ja]] || Neulasta || Cegfila, Fulphila, Grasustek, Pelgraz, Pelmeg, Udenyca, Stimufend, Ziextenzo
 |-
-| [[Ranibizumab]] || Lucentis || Byooviz, Ranivisio, Ximluci
+| [[Ranibizumab/ja]] || Lucentis || Byooviz, Ranivisio, Ximluci
 |-
-| [[Rituximab]] || MabThera || Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima
+| [[Rituximab/ja]] || MabThera || Blitzima, Ritemvia, Rituzena, Rixathon, Riximyo, Ruxience, Truxima
 |-
-| [[Somatropin]]  || Genotropin || Omnitrope
+| [[Somatropin/ja]]  || Genotropin || Omnitrope
 |-
-| [[Teriparatide]]  || Forsteo || Movymia, Terrosa
+| [[Teriparatide/ja]]  || Forsteo || Movymia, Terrosa
 |-
-| [[Tocilizumab]] || RoActemra || Tyenne
+| [[Tocilizumab/ja]] || RoActemra || Tyenne
 |-
-| [[Trastuzumab]] || Herceptin || Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac
+| [[Trastuzumab/ja]] || Herceptin || Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera, Zercepac
 |}
-</div>
-<div lang="en" dir="ltr" class="mw-content-ltr">
+== アメリカ ==
-== United States ==
+{{Anchor|United States}}
-</div>
-<div lang="en" dir="ltr" class="mw-content-ltr">
+===BPCI法===
-===BPCI Act===
+[[:en:Biologics Price Competition and Innovation Act of 2009|2009年生物製剤価格競争・革新法]]（Biologics Price Competition and Innovation Act of 2009: BPCI Act）は、2007年6月26日に[[:en:Ted Kennedy|エドワード・ケネディ]]上院議員（民主党）によって提唱・提出された。2010年3月23日にバラク・オバマ大統領によって署名された[[:en:Patient Protection and Affordable Care Act|患者保護と医療費負担適正化法]]（PPAC法）の下で正式に成立した。BPCI法は、公衆衛生法（PHS法）を改正し、[[Food and Drug Administration/ja|食品医薬品局]]（FDA）が承認した生物学的製剤と高度に類似（バイオシミラー）していることが実証された生物学的製剤について、短縮された承認経路を設けるものである。BPCI法は、1984年に連邦食品医薬品化粧品法（Federal Food, Drug, and Cosmetic Act：FFD&C法）を通じて生物学的製剤の承認を定めた薬物価格競争及び特許期間回復法（Drug Price Competition and Patent Term Restoration Act of 1984：ハッチ・ワックスマン法）と概念的に類似している。BPCI法は、薬物について既に知られていることを適切に利用することで、時間と資源を節約し、不必要な人体・動物実験の重複を避けるというFDAの長年の方針と一致している。FDAは、バイオシミラーまたはバイオ後続品開発に関連する合計4つのガイドライン草案を発表した。最初の3つのガイダンス文書が発表されると、FDAは2012年5月11日に公聴会を開催した。
-The [[Biologics Price Competition and Innovation Act of 2009|Biologics Price Competition and Innovation Act]] of 2009 (BPCI Act) was originally sponsored and introduced on June 26, 2007, by Senator [[Ted Kennedy|Edward Kennedy]] (D-MA). It was formally passed under the [[Patient Protection and Affordable Care Act]] (PPAC Act), signed into law by President Barack Obama on March 23, 2010. The BPCI Act was an amendment to the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to a [[Food and Drug Administration]] (FDA) approved biological product. The BPCI Act is similar, conceptually, to the Drug Price Competition and Patent Term Restoration Act of 1984 (also referred to as the "Hatch-Waxman Act") which created biological drug approval through the Federal Food, Drug, and Cosmetic Act (FFD&C Act). The BPCI Act aligns with the FDA's longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing. The FDA has released a total of four draft guidelines related to biosimilar or follow-on biologics development. Upon the release of the first three guidance documents the FDA held a public hearing on May 11, 2012.
-</div>
-<div lang="en" dir="ltr" class="mw-content-ltr">
+年、FDAはBPCIによる規制を実施するための「バイオシミラー行動計画」を発表し、[[evergreening/ja|エバーグリーニング]]のためのリスク評価・軽減戦略（REMS）制度の乱用の制限や、インスリンとヒト成長ホルモンを薬物ではなく生物製剤としての規制に移行させることなどが盛り込まれた。
-In 2018, the FDA released a Biosimilars Action Plan to implement regulations from the BPCI, including limiting the abuse of the Risk Evaluation and Mitigation Strategy (REMS) system for [[evergreening]] and transitioning insulin and human growth hormone to regulation as biologics rather than drugs.
-</div>
 ===アメリカで承認されたバイオシミラー===